CONCORDE BUL LOR 9X8X23, 5 DG
Report
- Report Number
- 1526439-2020-01914
- Event Type
- Injury
- Date Received
- October 8, 2020
- Date of Event
- September 18, 2020
- Report Date
- September 18, 2020
- Manufacturer
- MEDOS INTERNATIONAL SÃ RL CH
- Product Code
- MAX
- UDI-DI
- 10705034139494
- PMA / PMN Number
- K081917
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H4, H6: THE DHR OF PRODUCT CODE 187823408, LOT 215725, WAS REVIEWED AND NO NON-CONFORMANCE WAS OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON SEPTEMBER 20, 2018. QTY. (B)(4). THE DHR WAS ELECTRONICALLY REVIEWED. VISUAL INSPECTION: THE CONCORDE BUL LOR 9X8X23, 5 DG (P/N: 187823408, LOT NUMBER: 215725, QTY# 1) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION AT CQ, IT IS OBSERVED THAT THE DEVICE GOT BROKEN. MAJOR BROKEN PART WAS NOT RETURNED AT CQ. THUS, THE COMPLAINT IS BEING CONFIRMED. THE REPORTED EMBEDDED CONDITION CANNOT BE CONFIRMED WITHOUT ANY VISUAL EVIDENCE LIKE X-RAY OR SCAN REPORTS. DEVICE FAILURE/ DEFECT FOUND? YES. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION OF THE RECEIVED DEVICE WAS NOT PERFORMED AT CQ DUE TO POST MANUFACTURING DAMAGE. DOCUMENTATION/ SPECIFICATION REVIEW: THE FOLLOWING DRAWING(S) WAS REVIEWED: CONCORDE BULLET IMPLANTS OBLIQUE LORDOTIC, 9W X 23L. NO DESIGN ISSUES OR DISCREPANCIES WERE FOUND DURING THIS INVESTIGATION. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THE COMPLAINT IS BEING CONFIRMED FOR CONCORDE BUL LOR 9X8X23, 5 DG (P/N: 187823408, LOT NUMBER: 215725) AS THE DEVICE GOT BROKEN. WHILE A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED, IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES. THE REPORTED EMBEDDED CONDITION CANNOT BE CONFIRMED WITHOUT ANY VISUAL EVIDENCE LIKE X-RAY OR SCAN REPORTS. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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.
IT WAS REPORTED THAT ON (B)(6) 2020 DURING LUMBAR REVISION SURGERY, THE DEVICE WAS BROKEN. PRIOR TO INSTRUMENTATION WAS L3-5 WITH EXPEDIUM. THIS REVISION SURGERY WAS TO EXTEND THE CONSTRUCT TO L2-5 AND PERFORM A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L2/3. THE RODS AND SET SCREWS WERE REMOVED FROM THE PREVIOUS CONSTRUCT BUT THE EXISTING PEDICLE SCREWS WERE NOT REMOVED. NEW PEDICLE SCREWS WERE PLACED AT L2 UNDER NAVIGATION WITH MEDTRONIC STEALTH. THE DISCECTOMY WAS PERFORMED, AND THE ENDPLATES OF L2/3 WERE PREPARED. THE INTERBODY FUSION DEVICE WAS TO BE A CONCORDE BULLET (9W X 8H X 23L - 1878-23-408). THE SHAVERS AND AN 8MM TRIAL WERE USED. THE CAGE WAS INSERTED INTO THE DISC SPACE WITH MODERATE TO LIGHT RESISTANCE USING THE CONCORDE INSERTER. THE FINAL POSITION OUGHT TO BE SLIGHTLY ANTERIOR AS THE MOST DISTAL TANTELUM MARKERS WERE IN LINE WITH THE ANTERIOR BORDER OF THE VERTEBRAE. THE CAGE WAS PULLED BACK AND BROKE WITH THE INSERTER ATTACHED. DURING BREAKAGE OF THE CAGE THERE WAS NOT EXCESSIVE FORCE EXERTED, BUT A "POP" WAS HEARD. THE INSTRUMENT WAS CAUTIOUSLY REMOVED FROM THE DISC SPACE AND THE BREAKAGE WAS DISCOVERED. THE CAGE BROKE INTO TWO PIECES; THERE WERE NO SMALL FRAGMENTS FOUND. THE PROXIMAL PORTION OF THE CAGE WAS RECOVERED, WHILE THE DISTAL PORTION REMAINED IN THE DISC SPACE. THE SURGEON MADE MANY ATTEMPTS TO RETRIEVE THE DISTAL PORTION. THERE WAS SIGNIFICANT PRESSURE ON THE REMAINDER OF THE CAGE. PITUITARIES WERE USED TO GRAB THE CAGE WITHOUT SUCCESS. ADDITIONAL ACCESS WAS MADE ON THE CONTRALATERAL SIDE TO ACCESS THE DISC SPACE AND UTILIZE 8MM AND 9MM CONCORDE SPREADERS TO DISTRACT THE DISC SPACE AND ATTEMPT TO GET A HOLD ON THE CAGE WITH PITUITARIES AND ANGLED CURETTES. THE VERTEBRAE WERE ALSO SPREAD WITH RODS ATTACHED TO THE SCREWS AND USING THE EXPEDIUM DISTRACTOR. EVENTUALLY, A CURETTE WAS HOOKED INSIDE ONE OF THE SIDE HOLES OF THE CAGE, BUT THE CAGE DID NOT BUDGE. THE REMAINDER OF THE CAGE WAS IN A SATISFACTORY POSITION (NOT PROTRUDING BEYOND THE ANTERIOR EDGE OF THE VERTEBRAE) AND THE RISK OF DAMAGING THE ENDPLATES IN ORDER RETRIEVE THAT PORTION OF THE CAGE WAS TOO GREAT IN ADDITION TO POSSIBLE NERVE INJURY WITH EACH PASSING OF INSTRUMENTS INTO THE DISC SPACE. THE DISC SPACE WAS PACKED WITH AUTOGRAFT AND OSTEOAMP ALLOGRAFT. NEW RODS AND NEW SET SCREWS WERE USED TO COMPLETE THE L2-5 CONSTRUCT. THERE WAS A SURGICAL DELAY OF TWO (2) AND A HALF HOURS. THE PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN.
ADDITIONAL PRODUCT CODE MQP. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS JNJ REPRESENTATIVE. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. (B)(4). 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.
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A REVISION SURGERY. THIS REVISION SURGERY WAS TO EXTEND THE CONSTRUCT TO L2-5 AND PERFORM A TLIF AT L2/3 TREATING ADJACENT LEVEL DEGENERATION. RODS AND SET SCREWS WERE REMOVED FROM PREVIOUS CONSTRUCT BUT DID NOT REMOVE EXISTING PEDICLE SCREWS. SHE PLACED NEW PEDICLE SCREWS AT L2 UNDER NAVIGATION WITH MEDTRONIC STEALTH. SHE PROCEEDED TO PERFORM THE DISCECTOMY AND PREPARED THE ENDPLATES OF L2/3. THE SURGERY AND THE PATIENT OUTCOME WAS UNKNOWN. THERE WAS A SURGICAL DELAY OF 2.5 HOURS. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN CONCORDE INSERTER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN SHAVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN 8MM TRIAL/SPREADER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN PITUITARY (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN 9MM TRIAL/SPREADER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN ANGLED CURETTES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN EXPEDIUM DISTRACTOR (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) CONCORDE BUL LOR 9X8X23, 5 DG. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1115399 | CONCORDE BUL LOR 9X8X23, 5 DG | INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR | MAX | MEDOS INTERNATIONAL SÃ RL CH | 187823408 | 215725 | 10705034139494 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN CUTTING INSTRUMENTS| UNKNOWN INSERTION INSTRUMENTS| UNKNOWN LAMINA/PEDICLE/PROCESS HOOKS| UNKNOWN RODS| UNKNOWN SCREWS| UNKNOWN TRIALS| UNKNOWN CUTTING INSTRUMENTS| UNKNOWN INSERTION INSTRUMENTS| UNKNOWN LAMINA/PEDICLE/PROCESS HOOKS| UNKNOWN RODS| UNKNOWN SCREWS| UNKNOWN TRIALS |