VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 7 X 45MM
Report
- Report Number
- 1526439-2021-02177
- Event Type
- Death
- Date Received
- October 14, 2021
- Date of Event
- September 15, 2021
- Report Date
- September 15, 2021
- Manufacturer
- DEPUY SPINE INC
- Product Code
- PML
- UDI-DI
- 10705034411194
- PMA / PMN Number
- K160879
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
- 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY THE DEVICE WAS NOT RETURNED; HOWEVER, A PHOTO WAS RECEIVED AND EVALUATED. BASED ON THE PHOTOS, IT WAS OBSERVED THERE WERE TWO SCREWS THAT HAD MIGRATED FROM THEIR POSITION. HENCE THE ALLEGATION OF MIGRATION OF MIS TI CFX FEN POLY 7X45 CAN'T BE CONFIRMED. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE COMPLAINT CONDITION CAN'T BE CONFIRMED DURING PHOTO/VIDEO INVESTIGATION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. NO MANUFACTURING ISSUES WERE NOTED DURING INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. DEVICE HISTORY REVIEW THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A MRE REVIEW COULD NOT BE PERFORMED. IF MORE INFORMATION BECOME AVAILABLE, THE RECORD WILL BE RE-ASSESSED
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. H10 ADDITIONAL NARRATIVE: H3, H6: INVESTIGATION SUMMARY PHOTO INVESTIGATION: THE DEVICE WAS NOT RETURNED. A PHOTO-INVESTIGATION WAS PERFORMED ON THE IMAGES. UPON INSPECTING ALL THE IMAGES AND EMAIL COMMUNICATION PROVIDED UNDER NOTES & ATTACHMENTS SECTION, IT HAS BEEN OBSERVED THERE ARE TWO SCREWS WHICH HAVE BEEN MIGRATED FROM THEIR POSITION AND WE HAVE COMPLETED THE INVESTIGATION ON THOSE TWO SCREWS IN (B)(4), HENCE THE ALLEGATION OF MIGRATION OF MIS TI CFX FEN POLY 7X45 CAN'T BE CONFIRMED. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. CONCLUSION: THE COMPLAINT CONDITION CAN'T BE CONFIRMED DURING PHOTO/VIDEO INVESTIGATION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. NO MANUFACTURING ISSUES WERE NOTED DURING INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. DEVICE HISTORY REVIEW: THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A MRE REVIEW COULD NOT BE PERFORMED. IF MORE INFORMATION BECOME AVAILABLE, THE RECORD WILL BE RE-ASSESSED. 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. 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.
THIS IS REPORT 6 OF 10 FOR COMPLAINT (B)(4).
ADDITIONAL PRODUCT CODE: MNI. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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.
IT WAS REPORTED THAT, IN A LUMBAR SPINAL REVISION, THE PATIENT PASSED AWAY. THE PROCEDURE WAS ON (B)(6) 2021 TO REVISE A T12-L5 CONSTRUCT AND EXTEND THE CONSTRUCT TO T9. THE REVISION WAS TO ADDRESS SCREW PULL OUT ON THE RIGHT SIDE OF T12 AND L1. THE PATIENT HAD PREVIOUS LUMBAR SURGERIES. RADIOGRAPHS INDICATED THE PATIENT MAY HAVE ALIFS AND POSTERIOR FIXATION FROM L2-L5 WITH CLICK-X. A SUBSEQUENT SURGERY EXTENDED THE CONSTRUCT 2 ADDITIONAL LEVELS TO T12. IN THIS PROCEDURE, THE SURGEON DECIDED TO EXTEND THE CONSTRUCT 3 ADDITIONAL LEVELS TO T9 AND TO AUGMENT THE VERTEBRAL BODIES WITH CONFIDENCE CEMENT VIA VIPER FENESTRATED SCREWS. EACH LEVEL RECEIVED ABOUT 4-5CC OF CEMENT (~2CC PER SCREW). TOTAL CEMENT USED IS APPROXIMATELY 15CC. THE PROCEDURE WENT AS PLANNED. THE WOUND CLOSURE PROCESS WAS ALMOST COMPLETE AND THE PATIENT WENT INTO CARDIAC ARREST AND DIED. THIS REPORT IS FOR ONE (1) VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 7 X 45MM. THIS IS REPORT 6 OF 6 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1533081 | VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 7 X 45MM | BONE CEMENT, POSTERIOR SCREW AUGMENTATION | PML | DEPUY SPINE INC | 10705034411194 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | Death | CONFIDENCE KIT, NO NEEDLES| CONFIDENCE KIT, NO NEEDLES| CONFIDENCE KIT, NO NEEDLES| CONFIDENCE KIT, NO NEEDLES| CONN O/C ANGLD 5.5-6.35X5.5TI| CONN O/C ANGLD 5.5-6.35X5.5TI| CONN O/O SD TOP NTCH 5.5X5.5 T| CONN O/O SD TOP NTCH 5.5X5.5 T| MIS TI CFX FEN POLY 6X45| MIS TI CFX FEN POLY 6X45| MIS TI CFX FEN POLY 7X45| MIS TI CFX FEN POLY 7X45| MIS TI CFX FEN POLY 7X45| MIS TI CFX FEN POLY 7X45| MIS TI CFX FEN POLY 7X45| MIS TI CFX FEN POLY 7X45| MIS TI CFX FEN POLY 7X45| MIS TI CFX FEN POLY 7X45| SFX,5.5,TI, MED, SIZE A4| SFX,5.5,TI, MED, SIZE A4| SINGLE-INNER SETSCREW| SINGLE-INNER SETSCREW| TI PRCTRD ROD S 5.5MM| TI PRCTRD ROD S 5.5MM| VIPER2 LORDOTIC ROD-100MM| VIPER2 LORDOTIC ROD-100MM| VIPER2 LORDOTIC ROD-150MM| VIPER2 LORDOTIC ROD-150MM |