COLLECT.NO.QAS SPINE CERVICAL STABILIS.

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A COMPONENT OF THE ABC PLATE SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, A REMOVAL OF THE PLATE WAS SCHEDULED FOR (B)(6)2024. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, REVISION SURGERY. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G2 - REPORT SOURCE ADDED. H6 - CODES UPDATED. INVESTIGATION RESULTS: THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS BASED UPON HISTORICAL DATA ANALYSIS, AND EVENT DESCRIPTION. BATCH HISTORY REVIEW: THE BATCH NUMBER WAS NOT PROVIDED AND BATCH HISTORY REVIEW COULD NOT BE PERFORMED. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, REVISION SURGERY. CONCLUSION/PREVENTIVE MEASURES: DUE TO THE LACK OF INFORMATION SURROUNDING THE REPORTED CASE AND WITHOUT THE COMPLAINT SAMPLE BEING AVAILABLE FOR INVESTIGATION, A DEFINITE ROOT CAUSE CANNOT BE DETERMINED. IN THE EVENT THAT THE COMPLAINT SAMPLE WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.