{ "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. 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THE IMPLANT WAS REMOVED AND REPLACED WITH AN ALTERNATE TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT HARM." }, { "mdr_text_key": "321733870", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADDITIONAL INFORMATION: D4(EXPIRATION DATE, UDI NUMBER), D10, H3, H4, H6 (METHOD, RESULTS, CONCLUSIONS) PART: MC1341P THE COMPLAINT IS CONFIRMED THROUGH VISUAL INSPECTION OF PHOTOS FOR ONE (1) OF ONE (1) ROI-C CAGE (PN MC1341P) FOR THE FAILURE OF FRACTURE DURING INSERTION. MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. POTENTIAL CAUSE ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE GIVEN INFORMATION. DHR REVIEW AND RELATED ACTIONS PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. NO ACTIONS REQUIRED. THIS EVENT IS NOT RELATED TO ANY CURRENT ACTIONS OR RECALLS OR PRODUCT HOLDS. DEVICE USE AND COMPATIBILITY THIS DEVICE IS USED FOR TREATMENT. 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THERE WAS NO REPORTED PATIENT HARM." } ], "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": "11/13/2020" } ] }