COLLECT.NO.QAS SPINE ANTERIOR STABILIS.

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: 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. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED FOR THE AVAILABLE LOT NUMBER; THE DEVICE WAS FOUND TO BE WITHIN SPECIFICATION AT THE TIME OF PRODUCTION. 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. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

Additional Manufacturer Narrative

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., VIA THE ANNUAL ACTIVL ENHANCED SAFETY SURVEILLANCE STUDY (ESS) COVERING A REPORTING PERIOD FROM 01FEB2023 TO 31DEC2023, THAT AN UNKNOWN ACTIV L DEVICE WAS IMPLANTED ON AN UNSPECIFIED DATE AT THE LEVEL L4-L5 USING SPIKE ENDPLATE. ACCORDING TO THE COMPLAINANT THERE WAS A SUPPLEMENTAL FIXATION AT INDEX LEVEL 1. REPORTEDLY THE PATIENT'S NEUROLOGICAL STATUS WORSENED AND THERE WAS A DISABILITY DUE TO WORSENING BACK PAIN. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 2916714-2024-00066 AND 2916714-2024-00068.