BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURETAC II W/SPIKES

    MDR report key: 629210 · Received August 22, 2005

    Report

    Report Number
    1219602-2005-00102
    Event Type
    Other
    Date Received
    August 22, 2005
    Date of Event
    July 1, 2004
    Report Date
    August 18, 2005
    Manufacturer
    SMITH & NEPHEW, INC.ENDOSCOPY DIVISION
    Product Code
    HTN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BANKART TEAR WITH EXTENSION SUPERIORLY INTO A TYPE II SLAP. MODIFIED TRANSGLENOID REPAIR WITH 7-2/0 PDS SUTURES AND SURETACS IN 2004. SLOW REHABILITATION. AGGRESSIVE PHYSIO BUT RANGE OF MOTION RECOVERY STUCK AT 100 DEG. FF AND ABDUCTION; RE-SCOPED IN 02/2005. ADHESIONS AND SURETAC BREAKDOWN PRODUCTS AT SUPERIOR LABRUM. NO PROBLEMS ANTERIOR INFERIORLY AT SITE OF BANKART REPAIR. V SLOW ONLY GOT TO 140 DEG. FF 130 ABDUCTION, BUT PT CONSIDERS THIS SATISFACTORY FOR THEIR FUNCTIONAL DEMANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURETAC II W/SPIKES SURETAC II W/SPIKES HTN SMITH & NEPHEW, INC.ENDOSCOPY DIVISION 014567 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other