510K: THIS REPORT IS FOR AN UNKNOWN VERTEBRAL BODY REPLACEMENT MESH (SYNMESH QTY:1). PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. THE EXACT DATE IS UNKNOWN FOR (B)(6) 2017. DEVICE WAS NOT EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. NO INFORMATION DUE TO UNKNOWN PART. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
D
Patient 1
IT WAS REPORTED THAT ON AN UNKNOWN DAY IN (B)(6) 2017, THE PATIENT UNDERWENT AN ANTERIOR CORPECTOMY WITH A SYNMESH VERTEBRAL CAGE IMPLANTED AT C6 AND A CERVICAL SPINE LOCKING PLATE (CSLP) IMPLANTED AT C5-C7. THE TWO (2) C5 CSLP SCREWS BROKE BILATERALLY ON AN UNKNOWN DATE. ACCORDING TO THE SURGEON, THE SYNMESH CAGE ALSO APPEARED TO BE SLIGHTLY SUBSIDED IN BOTH ENDPLATES. REVISION SURGERY TOOK PLACE ON (B)(6) 2018, AND THE SAME SURGEON EXPLANTED THE CSLP PLATE. WHEN REMOVING THE PLATE, THE SURGEON DISCOVERED THAT ONE (1) C7 CSLP SCREW WAS BROKEN. THE SURGEON WAS UNABLE TO REMOVE ANY OF THE SCREW FRAGMENTS WHICH WERE IDENTIFIED AS ONE (1) IN C7 AND TWO (2) IN C5. THE SYNMESH CAGE WAS NOT REMOVED. THE SURGEON THEN COMPLETED THE ANTERIOR PORTION OF THE PROCEDURE BY PLACING THE SYNAPSE ROD SYSTEM HARDWARE AT C5-C7 TO STABILIZE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: CERVICAL SPINE LOCKING PLATE (PART# 450.231, LOT# UNKNOWN, QUANTITY# 1), LOCKING SCREW (PART# 497.78, LOT# UNKNOWN, QUANTITY# 3) THIS IS REPORT 4 OF 4 FOR (B)(4).