BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANODYNE

    MDR report key: 4961351 · Received July 30, 2015

    Report

    Report Number
    1935627-2015-00006
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    May 12, 2015
    Report Date
    July 29, 2015
    Manufacturer
    CORELINK, LLC
    Product Code
    KWQ
    PMA / PMN Number
    K121514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DHR SHOWED NO IRREGULARITIES IN THE PRODUCTION PROCESS FOR THIS PART. PHYSICAL REVIEW OF THE DRIVER TIP SHOWED SIGNS THAT THE DRIVER WAS ROTATED COUNTER CLOCKWISE WHEN THE TIP BROKE OFF. THE DRIVER IS INTENDED TO BE USED IN A CLOCKWISE FASHION. THE PHYSICIAN IDENTIFIED THAT THEY WERE ABLE TO LOCK ALL OTHER CERVICAL PLATE LOCKS WITHOUT ANY ISSUES IN THE SAME CASE.

    Description of Event or Problem · 1

    THE ANODYNE LOCKING CAP DRIVER SHAFT HEXLOBE TIP BROKE OFF WITHIN THE LOCKING CAP WHILE TIGHTENING THE CAP. (#2020-102). THE BROKEN PIECE WAS EMBEDDED WITHIN THE CAP AND COULD NOT BE REMOVED PER THE SURGEON. THE HOSPITAL DOCUMENTED THE INCIDENT IN AN "UNUSUAL INCIDENT REPORT". DURING A 2 LEVEL ACDF CASE. INITIAL COMMUNICATIONS IDENTIFIED FROM THE REP IDENTIFIED THAT THE SURGEON BELIEVED SHE TIGHTENED THE DRIVER TO HARD ON THE FIRST LOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498536 ANODYNE CERVICAL LOCK DRIVER KWQ CORELINK, LLC SM54905

    Patients

    Seq Age Sex Outcome Treatment
    1 Other