BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRLOCK VOLAR PLATE AND SCREW SYSTEM

    MDR report key: 778897 · Received November 7, 2006

    Report

    Report Number
    3005039508-2006-00001
    Event Type
    Other
    Date Received
    November 7, 2006
    Date of Event
    October 30, 2006
    Report Date
    November 7, 2006
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REVISION SURGERY WAS NOT NECESSITATED BY A FAILURE OF THE DEVICE. THE SURGEON REPORTS THAT THE REVISION WAS NEEDED TO TREAT ULNAR NERVE PALSY, A CONDITION NOT RELATED TO THE IMPLANT. THE SURGEON DOES NOT FAULT THE DEVICE IN ANY WAY; HOWEVER DURING A PREVIOUS COMPLAINT INVESTIGATION IT WAS DETERMINED THAT SOME OF THESE DEVICES DID NOT MEET MANUFACTURING SPECIFICATIONS. APPROPRIATE CORRECTIVE ACTION WAS TAKEN AND THE DEVICES WERE REMOVED FROM THE FIELD.

    Description of Event or Problem · 1

    ON 10-30-2006 ORTHOHELIX OBTAINED INFORMATION THAT, A REVISION SURGERY WAS PERFORMED IN WHICH OUR DRLOCK VOLAR DISTAL RADIUS PLATE WAS REMOVED. ON 11-6-2007, ORTHOHELIX WAS INFORMED THAT THE REVISION SURGERY WAS NOT BECAUSE OF A FAULTY IMPLANT BUT BECAUSE OF A CONDITION CALLED ULNAR NERVE PALSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRLOCK VOLAR PLATE AND SCREW SYSTEM ORTHOPEDIC IMPLANT HRS ORTHOHELIX SURGICAL DESIGNS, INC. * S200

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other