{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-29", "results": { "skip": 0, "limit": 1, "total": 196123 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MR.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "IRVINE", "manufacturer_contact_address_1": "13645 ALTON PKWY STE A", "manufacturer_contact_pcity": "77421003", "event_type": "Injury", "report_number": "3009161350-2026-01293", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260603", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250610", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "report_date": "20260602", "exemption_number": "", "manufacturer_contact_zip_code": "92618", "reporter_occupation_code": "DENTIST", "manufacturer_contact_plocal": "7742100390", "noe_summarized": "1", "manufacturer_contact_l_name": "LANZA", "source_type": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "92618", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "", "date_added": "20260603", "manufacturer_contact_f_name": "BRIAN", "device_date_of_manufacturer": "20231206", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1432785", "implant_date_year": "2025", "date_removed_year": "2025", "serviced_by_3rd_party_flag": "N", "date_received": "20260603", "brand_name": "ADVN+", "generic_name": "ADVANCED PLUS IMPLANT SP 3.75X13", "manufacturer_d_name": "PALTOP ADVANCED DENTAL SOLUTIONS INC.", "manufacturer_d_address_1": "13645 ALTON PKWY STE A", "manufacturer_d_address_2": "", "manufacturer_d_city": "IRVINE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92618", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "92618", "device_operator": "HEALTH PROFESSIONAL", "model_number": "20-70003P", "catalog_number": "20-70003P", "lot_number": "WO-029003", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20260602", "device_report_product_code": "DZE", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "07290108695779", "udi_public": "(01)07290108695779(17)290215(10)WO-029003", "openfda": { "device_name": "Implant, Endosseous, Root-Form", "medical_specialty_description": "Dental", "regulation_number": "872.3640", "device_class": "2" } } ], "product_problems": [ "Failure to Osseointegrate" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260605", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260603", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260602", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "date_report_to_manufacturer": "20260602", "manufacturer_contact_city": "IRVINE", "mdr_report_key": "25369715", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260602", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Replace" ], "manufacturer_g1_zip_code": "92618", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "PALTOP ADVANCED DENTAL SOLUTIONS INC.", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "403115809", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "FAILURE TO OSSEOINTEGRATE IS A WELL-KNOWN AND INHERENT RISK OF DENTAL IMPLANTS AND IS DOCUMENTED IN THE LITERATURE ACROSS IMPLANT SYSTEMS1, 2 (SEE E.G., KELLER, 1995; BORNSTEIN, 2008,).PALTOP DENTAL SOLUTIONS INC. PROVIDES IFU WITH ALL IMPLANTS. FAILURE TO OSSEOINTEGRATE, AND LOSS OF OSSEOINTEGRATION (IMPLANT MOBILITY) IS IDENTIFIED AS AN ADVERSE REACTION AND IDENTIFIED IN THE LIST OF WARNINGS IN ALL END-OSSEOUS DENTAL IMPLANT LABELLING. THE SPECIFIC CAUSE FOR A PARTICULAR COMPLAINT IS OFTEN NOT READILY IDENTIFIED AS THERE ARE VARIOUS FACTORS THAT CONTRIBUTE TO THE RISK OF IMPLANT FAILURE. THESE INCLUDE SYSTEMIC MEDICAL CONDITION (UNCONTROLLED DIABETES MELLITUS, AIDS, OSTEOPOROSIS), POOR BONE QUALITY AND QUANTITY OF BONE IN WHICH THE IMPLANT IS IMPLANTED, MEDICATIONS (CORTICOSTEROIDS, BISPHOSPHONATES), HARMFUL HABITS TO HEALING (SMOKING), SECONDARY INFECTION AND/OR SURGICAL TRAUMA, UNEXPERIENCED CLINICIAN, IMPROPER SURGICAL TECHNIQUE, OR MOBILITY OF THE IMPLANT LEADS TO ITS REMOVAL OR REPLACEMENT, HENCE DENTAL IMPLANT FAILURE. IN ADDITION, A RATE OF IMPLANT FAILURE THAT DOES NOT AFFECT THE PRODUCTS' RISK ASSESSMENT DOES NOT REQUIRE INVESTIGATION AS IT IS A WELL-KNOWN FAILURE MODE WHICH HAS BEEN ADEQUATELY STUDIED IN THE PAST." }, { "mdr_text_key": "403115810", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "FAILED TO OSSEOINTEGRATE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "13645 ALTON PKWY STE A", "distributor_zip_code": "", "manufacturer_contact_postal_code": "92618", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }