BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWINFIX AB ANCHOR

    MDR report key: 17531792 · Received August 12, 2023

    Report

    Report Number
    MW5138703
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    September 9, 2015
    Manufacturer
    SMITH AND NEPHEW
    Product Code
    MBI
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PLEASE BE INFORMED THAT AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE, DEPUY SYNTHES NOTED A POTENTIAL ADVERSE EVENT REGARDING A NON-SYNTHES PRODUCT. THE EVENT ALSO INVOLVED A DEPUY SYNTHES PRODUCT AND WAS RECORDED AS COMPLAINT FILE COM-131178. DEPUY SYNTHES SUBMITTED THE EVENT TO FDA AND SATISFIED REPORTING REQUIREMENTS. TWINFIX AB ANCHORS, SMITH AND NEPHEW, MANSFIELD, MASS. WARNER, J.J.P. ET AL. ANATOMICAL GLENOID RECONSTRUCTION FOR RECURRENT ANTERIOR GLENOHUMERAL INSTABILITY WITH GLENOID DEFICIENCY USING AN AUTOGENOUS TRICORTICAL ILIAC CREST BONE GRAFT. THE AMERICAN JOURNAL OF SPORTS MEDICINE, VOL. 34, NO. 2. ALL PATIENTS RETURNED TO PRE-INJURY LEVELS OF SPORT, AND ONLY 2 COMPLAINED OF MILD PAIN WITH OVERHEAD SPORTS ACTIVITIES. ALTHOUGH MOST PATIENTS REPORTED DISCOMFORT OVER THE BONE GRAFT DONOR SITE, NONE HAD COMPLAINTS OF PAIN AT THIS AREA 6 MONTHS AFTER SURGERY. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049520 TWINFIX AB ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH AND NEPHEW

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown