APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Additional Manufacturer Narrative

THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED TO AESCULAP INC. THAT AN AESCULAP CERVICAL PLATE AND SCREWS (PART # UNKNOWN) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT THE PATIENT WAS SCHEDULED FOR A REVISION PROCEDURE ON (B)(6) 2025. FOLLOW UP INFORMATION WAS RECEIVED ON JUNE 30, 2025, THAT THE SURGEON WAS UNABLE TO REMOVE THE HARDWARE THAT WAS IMPLANTED FROM AESCULAP IN THE PATIENT. REPORTEDLY THE PLATE WAS UNABLE TO BE REMOVED WITH THE SUGGESTED BAIL OUT DRIVERS. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT YET PROVIDED.

Additional Manufacturer Narrative

THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). INVESTIGATION RESULTS: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED AND NO PARTS WERE RETURNED FOR FAILURE ANALYSIS. THEREFORE, THE INVESTIGATION WAS NOT ABLE TO CONFIRM A DEVICE ISSUE THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. BATCH HISTORY REVIEW: THE DEVICE HISTORY RECORDS (DHR) WERE NOT ABLE TO BE REVIEWED AS NO LOT NUMBER WAS MADE AVAILABLE. HOWEVER, ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO DOCUMENTED PROCEDURES AND A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. CONCLUSION AND MEASURES / PREVENTATIVE MEASURES: A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.