BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSITCP INTERFERENCE SCREW

    MDR report key: 4476040 · Received January 23, 2015

    Report

    Report Number
    3004549189-2015-00001
    Event Type
    Injury
    Date Received
    January 23, 2015
    Date of Event
    December 30, 2014
    Report Date
    January 21, 2015
    Manufacturer
    SBM S.A.S.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREW IS BEING REPATRIATED TO EXPERTISE.

    Description of Event or Problem · 1

    SURGEON CLAIMS THE SCREW CUT THE SOFT TISSUE OF THE TENDON ATTEMPTED SOFT TISSUE FIXATION. "IT WAS REPORTED THAT DURING AN ANKLE RECONSTRUCTION ON (B)(6) 2014, THE SCREW CUT THE SOFT TISSUE OF THE TENDON CAUSING A SIX HOUR DELAY IN THE PROCEDURE. THE BONE DENSITY AND SIZE OF THE DRILLED HOLE MAY HAVE CONTRIBUTED TO THE SOFT TISSUE OF THE TENDON BEING CUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57005 COMPOSITCP INTERFERENCE SCREW FIXATION SCREW, BONE BIODEGRADABLE HWC SBM S.A.S. 110004604 141311

    Patients

    Seq Age Sex Outcome Treatment
    1 Other