BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER

    MDR report key: 6864180 · Received September 14, 2017

    Report

    Report Number
    1526439-2017-10736
    Event Type
    Malfunction
    Date Received
    September 14, 2017
    Date of Event
    August 11, 2017
    Report Date
    August 21, 2017
    Manufacturer
    DEPUY SPINE
    Product Code
    MNI
    UDI-DI
    10705034282695
    PMA / PMN Number
    K160879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. AN INVESTIGATION WILL BE CONDUCTED AND A FOLLOW UP FILED WITH THE FINDINGS IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). ONE (1) VIPER CORTICAL FIX FENESTRATED BOTTOM LOADING 7X55MM POLYAXIAL SCREW [PRODUCT CODE: 1867-27-755, LOT NO: 101598] WAS RETURNED TO THE CUSTOMER QUALITY UNIT (CQU) FOR EVALUATION. VISUAL EXAMINATION FOUND THAT THE POLYAXIAL¿S TULIP HEAD HAD BECOME DETACHED FROM THE POLYAXIAL¿S SCREW SHANK. NO DAMAGE WAS FOUND TO THE POLYAXIAL SCREW SHANK. ALSO, SWAGE MARKINGS WERE PRESENT INDICATIVE OF THE CAP BEING PROPERLY PLACED IN ITS INTENDED POSITION WITHIN THE TULIP HEAD. ALSO, THE INNER FLEX BALL WAS NOT RETURNED. AS A RESULT, IT IS BELIEVED THAT UNANTICIPATED HIGH AMOUNT OF FORCES WAS PLACED ON THE TULIP HEAD RESULTING IN THE TULIP HEAD BECOMING DETACHED FROM THE POLYAXIAL SCREW SHANK. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. A DEFINITIVE ROOT CAUSE FOR THE POLYAXIAL¿S TULIP HEAD BECOMING DETACHED FROM THE POLYAXIAL¿S SCREW SHANK CANNOT BE POSITIVELY DETERMINED. HOWEVER, VISUAL OBSERVATION SUGGESTS THAT UNANTICIPATED HIGH AMOUNT OF FORCES WAS PLACED ON THE TULIP HEAD RESULTING IN THE TULIP HEAD BECOMING DETACHED FROM THE POLYAXIAL SCREW SHANK. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS REQUIRING IMMEDIATE ACTION HAVE BEEN OBSERVED, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. 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 · 1

    THE CFX SCREW WAS INSERTED BY SURGEON PERCUTANEOUSLY. THE SCREW HEAD SLIGHTLY TOO CLOSE TO THE SCLEROTIC BONE, SO THEY SAT TOO DEEP AND THE SCREW WAS NOT MORE POLY-AXIAL. WHILE SCREW OUT THE SCREW, THE SCREW HEAD HAS LOOSEN FROM SCREW SHAFT. THE INNER PART OF SCREW HEAD COULD ONLY RECOVERED IN CRUMBLED ITEMS AND WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645397 VIPER ORTHOSIS, SPINAL PEDICLE FIXATION MNI DEPUY SPINE 186727755 101598 10705034282695

    Patients

    Seq Age Sex Outcome Treatment
    1