5.5 EXP VERSE UNITIZED SET SCR
Report
- Report Number
- 1526439-2020-01511
- Event Type
- Injury
- Date Received
- August 24, 2020
- Report Date
- July 25, 2020
- Manufacturer
- MEDOS INTERNATIONAL SÃ RL CH
- Product Code
- KWP
- UDI-DI
- 10705034466149
- PMA / PMN Number
- K142185
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. VISUAL INSPECTION: THE 5.5 EXP VERSE UNITIZED SET SCR (P/N: 199721001, LOT NUMBER: WE1112) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED THE THREADS WERE BROKEN AND DEFORMED. NO X-RAYS OR OTHER PHOTOGRAPHS WERE PROVIDED. DEVICE FAILURE/DEFECT IDENTIFIED? YES. FUNCTIONAL TEST: A FUNCTIONAL ASSESSMENT WAS UNABLE TO BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE OF THE COMPLAINT DEVICE. THUS, THE CONDITION CAN BE CONFIRMED AND REPLICATED SINCE THE SETSCREW CANNOT THREAD ONTO THE RETURNED CONCOMITANT SCREW. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE RECEIVED CONDITION MATCHES THE EVENT DESCRIPTION ALLEGATION MENTIONING THE SETSCREW MIGHT BE CROSSTHREADED, AND THE RECEIVED DEVICE IS UNABLE TO THREAD ON THE SCREW DUE TO DAMAGE. NO X-RAYS OR OTHER PHOTOGRAPHS WERE RETURNED, HOWEVER THE DAMAGE ON THE DEVICE CAN CAUSE THE OBSERVED FAILURE. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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 HISTORY THE DHR OF PRODUCT CODE 199721001S, LOT WE1112, WAS REVIEWED AND NO NON-CONFORMANCE WAS OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON APRIL 11, 2019. QTY.(B)(4). THE DHR WAS ELECTRONICALLY REVIEWED. 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.
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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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.
UPDATED: CONCOMITANT DEVICE REPORTED: ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); 5.5 EXP VERSE CAN SCR 6.0X45 (PART# 199725645, LOT# 221038, QUANTITY 1).
ADDITIONAL DEVICE PRODUCT CODES: OSH; MNI; KWQ; MNH; NKB. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SECOND REVISION SURGERY ON (B)(6) 2020 DUE TO SETSCREW LOOSENING AND THE ROD WAS ABOUT TO COME OFF THE SCREWHEAD. ALL THE SETSCREWS WERE REMOVED AND ANOTHER MANUFACTURER¿S SETSCREWS WERE USED AS REPLACEMENTS, AND RE-FUSION WAS PERFORMED TO TREAT ADJACENT DISEASE. THE SURGEON COMMENTED THAT THERE MIGHT HAVE BEEN CROSS-THREADING ON THE SETSCREW. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT (B)(4) IS RELATED TO COMPLAINT (B)(4), WHICH REPORTS THE FIRST REVISION PROCEDURE WHICH WAS PERFORMED FOR REMOVING THE BLOOD TUMOR BY DETACHING A CROSS-LINK DEVICE AND REPLACING WITH A NEW ONE. CONCOMITANT DEVICE REPORTED: ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); 5.5 EXP VERSE CAN SCR 6.0X45 (PART# 199725645S, LOT# 221038, QUANTITY 1). THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE UNITIZED SET SCR. THIS IS REPORT 1 OF 2 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 910328 | 5.5 EXP VERSE UNITIZED SET SCR | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MEDOS INTERNATIONAL SÃ RL CH | WE1112 | 10705034466149 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | 5.5 EXP VERSE CAN SCR 6.0X45| UNKNOWN RODS| UNKNOWN RODS |