CONFIDENCE KIT, NO NEEDLES
Report
- Report Number
- 1526439-2025-00530
- Event Type
- Death
- Date Received
- April 23, 2025
- Date of Event
- January 1, 2025
- Manufacturer
- DEPUY SPINE INC
- Product Code
- NDN
- UDI-DI
- 10705034209630
- PMA / PMN Number
- K060300
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). 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. H11 ADDITIONAL NARRATIVE: D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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. H11 ADDITIONAL NARRATIVE: ADDED: B5 AND D10 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. H11 ADDITIONAL NARRATIVE: ADDED: D4 (EXPIRY DATE), G1 (MANUFACTURING SITE NAME), H4 CORRECTED: D4 (PRIMARY UDI NUMBER). 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. DEVICE HISTORY REVIEW (DHR): A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 283913000421387 LOT NUMBER: IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES/MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 23 JAN 2025 MANUFACTURING SITE: JABIL LE LOCLE EXPIRY DATE: 31 DEC 2026 CEMENT: PART # 183901001/ LOT # 4572175. 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: A2 (DOB, AGE), A3A (SEX), B5 CORRECTED: H6 (HEALTH EFFECT - IMPACT CODE) IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
IN A REVISION SURGERY FOR SPINAL FIXATION DUE TO VERTEBRA T10 COLLAPSE AND A FRACTURE AT VERTEBRA L5 IN A PATIENT WITH SEVERE OSTEOPOROSIS, IT WAS DECIDED TO PERFORM FIXATION FROM VERTEBRA T8 DOWN TO THE PELVIS. AFTER INSERTING ALL 18 SCREWS, DECOMPRESSION WAS PERFORMED, AND THE SURGEON BEGAN INJECTING CEMENT INTO THE VERTEBRAE. 4 CEMENT KITS WERE INJECTED, DURING WHICH THE PATIENT EXPERIENCED, TWICE, A DROP IN THE PULSE AND BLOOD PRESSURE, WAS STABILIZED AND THE SURGEON DECIDED TO CONTINUE WITH THE SURGERY. THEREAFTER, AND PRIOR TO PROCEEDING TO INJECT AN ADDITIONAL CEMENT KIT, THE SURGEON NOTICED MASSIVE BLEEDING IN THE SURGICAL AREA THAT HAD BEEN COVERED WITH A STERILE DRAPE AND HAD NOT BEEN OBSERVED BEFORE. THE SURGEON TRIED TO CONTROL THE BLEEDING AND THE PATIENT'S BLOOD PRESSURE AND PULSE DROPPED SHARPLY. AN ADDITIONAL SENIOR SURGEON JOINED THE SURGERY AND RESUSCITATION EFFORTS BEGAN, BUT ULTIMATELY, THEY HAD TO DECLARE HER DEATH.
ADDITIONAL INFORMATION RECEIVED STATES THAT THE ORIGINAL KYPHOPLASTY DID INVOLVE DEPUY SYNTHES CEMENT AND DEPUY SYNTHES SCREWS.
ADDITIONAL INFORMATION RECEIVED: A. IT WAS MENTIONED THAT THIS WAS A REVISION SURGERY. WHAT WAS THE ORIGINAL SURGERY, AND WHEN WAS IT PERFORMED? WHAT WAS THE REASON FOR THE REVISION? REVISION SURGERY OF KYPHOPLASTY B. ARE ANY PREOP OR INTRAOPERATIVE IMAGES AVAILABLE? NO. C. ANY DEVICE MALFUNCTIONING WAS NOTICED? NO. D. WHAT IS THE SURGEON'S ASSESSMENT OF THE CAUSE OF DEATH? DAMAGE TO BLOOD VESSELS, LATER DETECTION OF BLEEDING. E. CAN THE AUTOPSY REPORT BE SHARED? IF NOT, WHAT¿S THE CONCLUSION OF THE REPORT? NO, THE FAMILY DECIDED NOT TO MAKE AUTOPSY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1291187 | CONFIDENCE KIT, NO NEEDLES | CEMENT, BONE, VERTEBROPLASTY | NDN | DEPUY SPINE INC | 421387 | 10705034209630 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Female | Death | CONFIDENCE KIT, NO NEEDLES| CONFIDENCE KIT, NO NEEDLES| CONFIDENCE KIT, NO NEEDLES |