BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIS TI CFX FEN POLY 7X45

    MDR report key: 12830314 · Received November 17, 2021

    Report

    Report Number
    1526439-2021-02429
    Event Type
    Death
    Date Received
    November 17, 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
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PROCODE: MNI. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. FAX NUMBER REPORTED AS (B)(6). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LUMBAR SPINAL REVISION ON (B)(6) 2021, THE PATIENT PASSED AWAY. THE PROCEDURE WAS INTENDED 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 ANTERIOR LUMBAR INTERBODY FUSIONS (ALIFS) AND POSTERIOR FIXATION FROM L2-L5 WITH THE CLICK-X SYSTEM. A SUBSEQUENT SURGERY EXTENDED THE CONSTRUCT TWO ADDITIONAL LEVELS TO T12. IN THIS PROCEDURE, THE SURGEON DECIDED TO EXTEND THE CONSTRUCT THREE 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, WHEN THE PATIENT WENT INTO CARDIAC ARREST AND DIED. THIS REPORT IS FOR A MIS TI CFX FEN POLY 7X45. THIS IS REPORT 10 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1727833 MIS TI CFX FEN POLY 7X45 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| CONN O/C ANGLD 5.5-6.35X5.5TI| CONN O/O SD TOP NTCH 5.5X5.5 T| 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| SFX,5.5,TI, MED, SIZE A4| SINGLE-INNER SETSCREW| TI PRCTRD ROD S 5.5MM| VIPER2 LORDOTIC ROD-100MM| VIPER2 LORDOTIC ROD-150MM