inforMED
InjuryEZX

UNK - VERTEBRAL BODY REPLACEMENT - MESH: SYNMESH

Received Oct 8, 2021

Report 8030965-2021-08532 · MDR key 12601815

Device

Generic name

Surgical Mesh

Manufacturer

Synthes Gmbh

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Appropriate Device Problem Term/Code Not Available
  • Adverse Event Without Identified Device or Use Problem
  • Appropriate Device Problem Term/Code Not Available

Patient

Not reported

  • Bone Fracture(s)
  • Perforation of Vessels
  • Unspecified Tissue Injury
  • Bone Fracture(s)
  • Perforation of Vessels
  • Unspecified Tissue Injury

Narrative

Additional Manufacturer Narrative

THIS REPORT IS FOR AN UNK - VERTEBRAL BODY REPLACEMENT - MESH: SYNMESH/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J EMPLOYEE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.

Description of Event or Problem

THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) FOR PATIENTS WHO WERE TREATED WITH DEPUY SYNTHES SPINE LLIF THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED AS PER THE SPINE TANGO REPORT: 2 PATIENTS DIED/ INTRAOP GENERAL COMPLICATIONS: 2 COMPLICATIONS WERE NOT DOCUMENTED. INTRAOP ADVERSE EVENTS: 6 COMPLICATIONS WERE DURAL LESIONS, 2 COMPLICATIONS WERE VASCULAR INJURY, 2 COMPLICATIONS WERE FRACTURE VERTEBRAL STRUCTURES, AND 2 WERE OTHER COMPLICATIONS. POSTOP GENERAL BEFORE DISCHARGE: 3 COMPLICATIONS WERE CARDIOVASCULAR, 1 COMPLICATION WAS PULMONARY, 1 COMPLICATION WAS THROMBOEMBOLISM, AND 3 COMPLICATIONS WERE NOT DOCUMENTED. POSTOP SURGICAL BEFORE DISCHARGE: 1 COMPLICATION WAS SENSORY DYSFUNCTION, 1 COMPLICATION WAS WOUND INFECTION SUPERFICIAL, 11 WERE OTHER COMPLICATIONS, AND 3 COMPLICATIONS WERE NOT DOCUMENTED. REOPERATIONS: 4 PATIENTS HAD REOPERATIONS. THIS REPORT IS FOR AN UNKNOWN ACIS, CERVIOS, CERVIOS CHRONOS, CHRONOS, CSLP, FACET WEDGE, ECD, MATRIX, OPAL, ORACLE, STENOFIX, SYNAPSE, SYNEX, SYNFIX EVOLUTION, SYNFLATE, SYNMESH, T-PAL, USS SMALL STATURE, USS, USS FRACTURE, USS FX MIS, VECTRA, VBS, VERTECEM, XRL, ZERO-P, ZERO-P VA. THIS REPORT IS FOR (1) UNK - VERTEBRAL BODY REPLACEMENT - MESH: SYNMESH. THIS IS REPORT 1 OF 13 FOR COMPLAINT (B)(4).