BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUSPENSION AC JOINT INJURY REPAIR SYSTEM

    MDR report key: 2182756 · Received July 11, 2011

    Report

    Report Number
    3008770958-2011-00001
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 13, 2011
    Report Date
    July 11, 2011
    Manufacturer
    SUSPENSION ORTHOPAEDIC SOLUTIONS LLC
    Product Code
    JDR
    PMA / PMN Number
    K102143
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOLLOWING THE REVISION SURGERY AND IS BEING EVALUATED. THE SUTURE WAS BROKEN BUT NO CLEAR CAUSE OF THE EVENT COULD BE IMMEDIATELY DETERMINED. BASED ON DISCUSSION WITH THE EVENT REPORTER, THE MOST LIKELY CAUSE OF THIS EVENT (BASED ON THE PT'S COMMENTS TO THE PHYSICIAN) IS NON-COMPLIANCE WITH THE POST-OPERATIVE PROTOCOL. NEVERTHELESS, THE RETRIEVAL SAMPLE IS BEING FULLY EVALUATED. ANY ADD'L, RELEVANT INFO OBTAINED WILL BE ADDRESSED IN A SUBSEQUENT REPORT. DEVICE HISTORY RECORD AND COMPLAINTS HISTORY REVIEWS REVEALED NOTHING RELEVANT TO THIS EVENT.

    Description of Event or Problem · 1

    ABOUT A WEEK AFTER INITIAL SURGERY FOR ACUTE AC INJURY, PT REPORTS BEING OUT OF HIS SLING AND MOVING HIS ARM IN AN ADDUCTED POSITION ACROSS HIS BODY WHEN HE FELT A PAINLESS POP IN HIS SHOULDER. PT PRESENTED TO PHYSICIAN'S OFFICE WHERE X-RAYS REVEALED A LOSS OF REDUCTION OF THE AC JOINT. OPTIONS WERE DISCUSSED WITH THE PT, AND THE PT ELECTED TO HAVE REVISION SURGERY. DURING THE REVISION PROCEDURE, IMPLANT WAS FOUND TO BE INTACT AND IN PLACE WITH THE EXCEPTION OF A BROKEN SUTURE. THE ORIGINAL IMPLANT WAS REMOVED AND THE CASE WAS COMPLETED SUCCESSFULLY. EVENT REPORTER REPORTED THAT THE PT'S SUBSEQUENT POST-OPERATIVE COURSE REMAINS UNREMARKABLE AND THE PT CONTINUES TO DO WELL. NO ADD'L ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUSPENSION AC JOINT INJURY REPAIR SYSTEM SOFT TISSUE FIXATION FASTENER JDR SUSPENSION ORTHOPAEDIC SOLUTIONS LLC 126-11

    Patients

    Seq Age Sex Outcome Treatment
    1 Other