{ "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": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "MW5120512", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20230802", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20230727", "reprocessed_and_reused_flag": "", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "RISK MANAGER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20230807", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "772402", "implant_date_year": "2021", "date_removed_year": "2023", "serviced_by_3rd_party_flag": "N", "date_received": "20230802", "brand_name": "STRYKER / MAKO / 2KM OZARK 2 LEVEL CERVICAL PLATE", "generic_name": "APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY", "manufacturer_d_name": "K2M / STRYKER SPINE", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "KWQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Appliance, Fixation, Spinal Intervertebral Body", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3060", "device_class": "2" } } ], "reporter_state_code": "NJ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20230802", "sequence_number_treatment": [ "SCREWS.", " SPINAL CAGES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "69 YR", "patient_sex": "Male", "patient_weight": "82 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Failure of Implant", "Failure of Implant" ] } ], "distributor_city": "", "date_report": "20230731", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "17450739", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Voluntary report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "320500777", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "PT (PATIENT) HAD HARDWARE PLACED (B)(6) 2021 AND ON FOLLOW UP X-RAY, CT (COMPUTED TOMOGRAPHY) AND MRI (MAGNETIC RESONANCE IMAGING) REVEALED THE BACKING OUT OF THE SCREWS AT C5 LEVEL AS WELL AS A BROKEN LOCKING MECHANISM. (B)(6) 2023: PT HAD SURGERY: REVISION ANTERIOR CERVICAL APPROACH REMOVAL OF OLD HARDWARE REVISION OF C4-5 FUSION RE INSTRUMENTATION FROM C3 TO C5 THE CAGES USED (B)(6) WERE: 1. IMPLANT-INTRBDY CERV POR CASCADIA 13X16X7 ¿ SNONE 2. IMPLANT-INTRBDY CERV POR CASCADIA 13X16X7 ¿ SNONE (LOOKS LIKE THEY USED THE SAME SIZE CAGES FOR BOTH LEVELS) THE PLATE USED WAS: PLATE 2 LEVEL OZARK VIEW 40MM ¿ SNONE THE SCREWS USED WERE: SCREW VARI SELF-START OZARK 4X16MM ¿ SNONE (THERE WERE MOST LIKELY 6 SCREWS, LOOKS LIKE ALL WERE SAME SIZE) COMPANY AT THE TIME OF INITIAL SURGERY IN 2021 IS K2M- COMPANY NAME CHANGED TO STRYKER. REFERENCE REPORTS: MW5120510 AND MW5120511." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }