BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 EXP VERSE CAN SCR 7.0X40

    MDR report key: 13094864 · Received December 28, 2021

    Report

    Report Number
    1526439-2021-02656
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Date of Event
    November 29, 2021
    Manufacturer
    DEPUY SPINE INC
    Product Code
    NKB
    PMA / PMN Number
    K142185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. H3, H4, H6: PART 199725740S, LOT 265093: THE PRODUCT WAS RELEASED ON: (B)(6) 2019. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND NO NON-CONFORMANCES/MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. H3, H6: A PHOTO INVESTIGATION WAS COMPLETED: VISUAL ANALYSIS OF THE PROVIDED IMAGES REVEALED THAT THERE WAS NO DAMAGE OR DEFECTS. A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS THE DEVICE WAS NOT RETURNED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE DEVICE WAS FOUND TO HAVE NO DAMAGE OR DEFECTS. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. 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 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL PRODUCT CODE: KWP;KWQ;MNH;MNI;OSH. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; 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.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REVISION SURGERY. DURING THE SURGERY, L6 SCREWS FOUND LOOSE, AND THE CAGE HAD NOT BEEN SECURED TO THE LESION AND COME OFF THE LESION. THE SURGERY IS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED. UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). UNKNOWN SET SCREW (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS COMPLAINT INVOLVES (3) DEVICES. THIS REPORT IS FOR (1) 5.5 EXP VERSE CAN SCR 7.0X40. THIS REPORT IS 2 OF 2 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1993219 5.5 EXP VERSE CAN SCR 7.0X40 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB DEPUY SPINE INC 265093

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male 5.5 EXP VERSE CAN SCR 7.0X40| T-PAL PROTI, 10X10X28 MM| UNK - LOCKING/SET SCREWS: EXPEDIUM VERSE| UNK - RODS: EXPEDIUM VERSE