CONF PERIMETER MESH KIT

Additional Manufacturer Narrative

(B)(4). A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

PERIMETER MESH PRESENTS DEFECT DUE TO CEMENT LEAKAGE, WHICH IS NOT CONTAINED WITHIN THE MESH AND ALLOWS THE CEMENT TO DISPERSE TOWARDS THE ANTERIOR PART OF THE VERTEBRA WITHOUT FULFILLING THE FUNCTION OF RECOVERING THE HEIGHT OF THE VERTEBRAL BODY. PATIENT CONSEQUENCE?: YES. PATIENT CONSEQUENCE DESCRIPTION:THE VERTEBRA DOES NOT RECOVER THE HEIGHT WITH THE CEMENT INJECTION THROUGH THE PERIMETER. ACTION TAKEN FOR PROCEDURE: ARTRODESAN FROM T11 TO L4 TO ENSURE THAT THE XIPHOSIS CAUSED BY THE INJURY IS CORRECTED. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES. PRODUCT 283922000, LOT 5218767. PATIENT (B)(6), WOMAN, (B)(6). SPINE PROCEDURE.