CONFIDENCE SPINAL CMT SYS, 11C
Report
- Report Number
- 1526439-2025-00826
- Event Type
- Malfunction
- Date Received
- July 2, 2025
- Date of Event
- January 1, 2025
- Manufacturer
- MEDOS INTERNATIONAL SÃ RL CH
- Product Code
- NDN
- UDI-DI
- 10705034209623
- PMA / PMN Number
- K060300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
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. H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. H3, H6: THE PRODUCT WAS NOT RETURNED TO MEDTECH ORTHOPEDICS; HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTOGRAPHS ATTACHED WERE REVIEWED, HOWEVER THEY DO NOT REPRESENT THE REPORTED COMPLAINT CONDITION. THEREFORE, THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT DUE TO THE INSUFFICIENT EVIDENCE PROVIDED. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE PHOTOGRAPHS PROVIDED ARE NOT REPRESENTATIVE OF THE REPORTED COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF MEDTECH ORTHOPEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW A DHR EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 283910000 LOT NUMBER: 418925 NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. 1 NR LINKED TO THIS LOT WAS FOUND: JBL-NR-0031453 IS LINKED TO WRONG CEMENT COMPONENT USED FOR THIS LOT: ITEM 183907001/LOT 4572177 INSTEAD OF ITEM 183901001/LOT 4572175. AFTER REWORK, THE CEMENT WAS REPLACED WITH THE CORRECT CEMENT REFERENCE. THE PRODUCT WAS RELEASED ON: 20 DEC 2024 EXPIRY DATE: 30 NOV 2026 MANUFACTURING SITE: JABIL LE LOCLE IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT 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 DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: H3, H6: THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE PUMP IN THE KIT WAS NEARLY EMPTY, AND THE CEMENT CONTAINER WAS FOUND TO BE HARDENED. NO OTHER ISSUES WERE OBSERVED. A FUNCTIONAL TEST WAS PERFORMED, AND NO ISSUES WERE FOUND IN THE CONNECTION BETWEEN THE PUMP AND THE CEMENT CONTAINER. HOWEVER, DUE TO THE ABSENCE OF LIQUID, IT WAS NOT POSSIBLE TO DETERMINE WHETHER THERE WAS ANY LEAKAGE AT THE CONNECTION POINT. ADDITIONALLY, A RETAIN TEST WAS PERFORMED BY THE VENDOR BLACKPOOL, THE RESULT OF THE TESTING REVEALED NO DEVIATIONS FOR PRODUCT CODE 183901001 / LOT: 4572175. A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS IT IS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE CONFIDENCE SPINAL CMT SYS, 11C WOULD HAVE NOT CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW A DHR EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 283910000 LOT NUMBER: 418925. NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. 1 NR LINKED TO THIS LOT WAS FOUND: JBL-NR-0031453 IS LINKED TO WRONG CEMENT COMPONENT USED FOR THIS LOT: ITEM 183907001/LOT 4572177 INSTEAD OF ITEM 183901001/LOT 4572175. AFTER REWORK, THE CEMENT WAS REPLACED WITH THE CORRECT CEMENT REFERENCE. THE PRODUCT WAS RELEASED ON: 20 DEC 2024 MANUFACTURING SITE: JABIL LE LOCLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. H3, H6 INVESTIGATION SUMMARY: THE PRODUCT WAS NOT RETURNED TO MEDTECH ORTHOPEDICS; HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTOGRAPHS ATTACHED WERE REVIEWED, HOWEVER THEY DO NOT REPRESENT THE REPORTED COMPLAINT CONDITION. THEREFORE, THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT DUE TO THE INSUFFICIENT EVIDENCE PROVIDED. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE PHOTOGRAPHS PROVIDED ARE NOT REPRESENTATIVE OF THE REPORTED COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF MEDTECH ORTHOPEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW (DHR): A DHR EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE. PRODUCT CODE: 283910000. LOT NUMBER: 418925. NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. THE PRODUCT WAS RELEASED ON: 20 DEC 2024. MANUFACTURING SITE: JABIL LE LOCLE.
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. H3, H6: 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.
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. H11 ADDITIONAL NARRATIVE: ADDED: B5. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED THAT AFTER THE INTRAOPERATIVE PUNCTURE NEEDLE WAS POSITIONED, THE BONE MUD WAS ASSEMBLED. THE PUNCTURE NEEDLE WAS LOCKED AS TIGHT AS POSSIBLE BEFORE THE BONE MUD WAS POURED IN. WHEN THE PRESSURE GUN WAS ROTATED, LESS THAN 1CC OF BONE MUD WENT IN AND WATER KEPT FLOWING OUT OF THE BOTTLE. THE ASSEMBLY WAS RE-CHECKED AND INSTALLED AGAIN AND WAS PRESSED TO POUR IN LESS THAN 2CC. THERE WAS STILL WATER LEAKAGE AT THE JOINT. THE SUPERVISOR AND THE DOCTOR REPEATED THE TEST OF THE ASSEMBLY AND TESTED OUT ALL THE WATER. THEN SALES REP IMMEDIATELY PUT IN ANOTHER BOX AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS A TYPO FOR THE ALERT DATE. THE CORRECTED ALERT DATE SHOULD BE CORRECTED TO (B)(6) 2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9141 | CONFIDENCE SPINAL CMT SYS, 11C | CEMENT, BONE, VERTEBROPLASTY | NDN | MEDOS INTERNATIONAL SÃ RL CH | 418925 | 10705034209623 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |