TEMPOROMANDIBULAR JOINT-PATIENT MATCHED IMPLANT

Additional Manufacturer Narrative

(B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THE PRODUCT WAS IMPLANTED INTO THE PATIENT AND THEREFORE WILL NOT BE RETURNED FOR AN EVALUATION. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

Description of Event or Problem

IT WAS REPORTED THAT A TEMPLATE AND A FOSSA IMPLANT FROM A TEMPORMANDIBULAR JOINT (TMJ) PATIENT MATCHED IMPLANT (PMI) SYSTEM WERE MISSING A HOLE. IT IS REPORTED THAT THE SURGEON CREATED THE MISSING HOLES. IT WAS REPORTED THAT THIS EVENT PRESENTED NO DELAY TO THE PROCEDURE AND NO INJURY TO THE PATIENT.

Additional Manufacturer Narrative

THE COMPLAINT IS THE SUTURE HOLE IS MISSING FROM THE FOSSA TEMPLATE AND IMPLANT. THE COMPLAINT WAS CONFIRMED THROUGH INTRAOPERATIVE PICTURES. THE MOST LIKELY UNDERLYING CAUSE IS THE DESIGN VENDOR SENDING THE INCORRECT REVISION OF THE CAD (COMPUTER AIDED DESIGN) FILE TO ZIMMER BIOMET FOR MANUFACTURE.