BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBOUND HRD

    MDR report key: 6215777 · Received December 30, 2016

    Report

    Report Number
    3005770977-2016-00001
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Report Date
    December 28, 2016
    Manufacturer
    ARB MEDICAL, LLC
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO THE MANUFACTURER. METAL FATIGUE IS SUSPECTED SEPARATION CAUSE. THIS TYPE OF SEPARATION IS RARE (ESTIMATED AT (B)(4) OF DEVICES IMPLANTED). THIS EVENT IS BEING REPORTED BECAUSE ALTHOUGH THE PATIENT HAS NO PERMANENT INJURY OR SERIOUS DETERIORATION TO HEALTH THE DEVICE WAS REMOVED.

    Description of Event or Problem · 1

    EIGHT MONTHS AFTER IMPLANTATION, PATIENT WAS X-RAYED. A SEPARATED FRAME OF THE DEVICE WAS OBSERVED ON THE X-RAY. DEVICE WAS EXPLANTED AT A LATER DATE WITH NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865416 REBOUND HRD FTL ARB MEDICAL, LLC RB-SLD-LSO-PP 150006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other