EXPEDIUM

Description of Event or Problem

ON (B)(6) 2020, THE PATIENT WAS INVOLVED IN A CAR COLLISION AND WAS AIRLIFTED TO (B)(6). ON (B)(6) 2020, THE PATIENT UNDERWENT AN OCCIPUT-C3 POSTERIOR SPINAL FUSION WHERE BONE SCREWS AND TITANIUM RODS WERE PLACED IN HER CERVICAL SPINE. THE PROCEDURE WAS PERFORMED PURSUANT TO THE STANDARD OF CARE AND PATIENT TOLERATED THE PROCEDURE WELL. PATIENT'S PHYSICAL AND MENTAL HEALTH IMPROVED GREATLY AFTER THIS SURGERY. ON (B)(6) 2020, THE PATIENT INFORMED (B)(6) ABOUT THE VEHICULAR COLLISION AND REQUESTED PAIN MANAGEMENT. ON (B)(6) 2020, X-RAYS LEFT THE IMPRESSION OF AN INSTRUMENTED POSTERIOR SPINAL FUSION AND POSTERIOR DECOMPRESSION FROM THE OCCIPUT THROUGH C3 FOR MANAGEMENT OF CERVICAL SPINE FRACTURES. ALSO, X-RAYS HER RIGHT SHOULDER SHOWED CLAVICULAR FRACTURE AND THORACIC COMPRESSION FRACTURES AT THE T5 AND T6 LEVELS. PATIENT WAS DIAGNOSED WITH A CLOSED STABLE BURST FRACTURE OF FIRST CERVICAL VERTEBRAE WITH ROUTINE HEALING. ON (B)(6) 2020, IT WAS NOTED THAT THE PATIENT WAS UNDERGOING PHYSICAL THERAPY AND IMPROVING. ON (B)(6) 2020, CT SCANS OF THE CERVICAL AND THORACIC SPINE SHOWED: OCCIPUT-C3 POSTERIOR INSTRUMENTED FUSION WITHOUT EVIDENCE FOR HARDWARE FAILURE, AND FRACTURES AT THE T3-T6 LEVELS. ON (B)(6) 2020, THE PATIENT WAS TREATED AT ASSOCIATED PHYSICIAN GROUP, LIMITED FOR PAIN MANAGEMENT AND WAS DIAGNOSED WITH CERVICALGIA AND PAIN IN THE THORACIC SPINE. ON (B)(6) 2020, X-RAYS OF THE CERVICAL AND THORACIC SPINE SHOWED THE POSTERIOR INSTRUMENTED SPINAL FUSION FROM THE OCCIPUT THROUGH C3 WITH MILD RESIDUAL LATERAL DISPLACEMENT OF C1 LATERAL MASSES AND T6 VERTEBRAL COMMINUTED SPLIT FRACTURE AND PARTIALLY VISUALIZED T3-T5 COMPRESSION FRACTURES. ON (B)(6) 2020, PHYSICAL EXAMINATION SHOWED THAT THE PATIENT WAS ABLE TO AMBULATE WITH A CANE, BUT EXPERIENCED PAIN IN HER MID THORACIC SPINE. THE SURGEON RECOMMENDED SURGICAL INTERVENTION TO STABILIZE HER THORACIC SPINE. ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO (B)(6) HOSPITAL IN THE CITY OF (B)(6). ON (B)(6) 2020, THE PATIENT UNDERWENT A POSTERIOR SPINAL FUSION OF T3-T9 THORACIC SPINE LEVELS. ON (B)(6) 2020, PHYSICAL EXAMINATION SHOWED THAT THE PATIENT STANDS WITH HER HEAD STOOPED FORWARD, ALMOST ON HER CHEST. SHE HAD TROUBLE MEETING MY GAZE. PATIENT COULD ONLY PASSIVELY LIFT HER HEAD UP AND HOLD IT FOR A FEW SECONDS. IT WAS OBSERVED THAT SHE WAS CHIN ON CHEST. THAT DAY THE PATIENT WAS ADMITTED TO (B)(6) HOSPITAL IN THE CITY OF (B)(6). ON (B)(6) 2020, THE PATIENT UNDERWENT A COMPLICATED SPINAL FUSION WITH ORTHOPEDIC SURGERY. SPECIFICALLY, SHE UNDERWENT A POSTERIOR SPINAL INSTRUMENTATION AND FUSION C4, 5, 6, T1, 2, 10, 11, 12, L1, L2, L3, L4 WITH DECORTICATION AND REVISION INSTRUMENTED FUSION OCC-C3, 13-9. DURING THIS PROCEDURE THE SURGEON PLACED THE BILATERAL RODS FROM OCCIPUT TO T5 WHILE REPOSITION THE HEAD IN THE MAYFIELD PINS TO REDUCE OUR KYPHOSIS FROM C7 TO T3. THIS WAS DONE SUCCESSFULLY. FURTHER, RODS WERE PLACED BILATERALLY FROM T7-L4. ADDITIONAL DEVICES ARE REPORTED UNDER (B)(4).

Additional Manufacturer Narrative

PRODUCT COMPLAINT#: (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. E3 INITIAL REPORTER OCCUPATION: LAWYER. H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.