AE-QAS-SP42

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 (B)(6) 2023 AT THE L4-5 LEVEL. ACCORDING TO THE COMPLAINANT THE PATIENT EXPERIENCED A SENSORY NEUROLOGICAL EVENT ON AN UNSPECIFIED DATE. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). REFERENCE ASSOCIATED MEDWATCH REPORTS. 2916714-2024-00015 2916714-2024-00017 2916714-2024-00018 2916714-2024-00019 2916714-2024-00020.

Additional Manufacturer Narrative

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.