BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THREADED INSERTER

    MDR report key: 3881841 · Received June 18, 2014

    Report

    Report Number
    1030489-2014-02783
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MSD BARTLETT MFG
    Product Code
    MAX
    PMA / PMN Number
    K073291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL EXAMINATION CONFIRMS THE SUPERIOR TANG IS BROKEN; THE BROKEN PIECE IS MISSING AND NOT RETURNED FOR ANALYSIS. FRACTURE INITIATION APPEARS TO BE LOCATED AT THE BASE OF THE TANG, CONSISTENT WITH BEND STRESS OVERLOAD. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACE REVEALS A FAIRLY QUASI-BRITTLE FRACTURE, WITH NO INDICATION OF FATIGUE. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH BEND STRESS OVERLOAD.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSERTER'S TIP BROKE DURING AN UNSPECIFIED SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357413 THREADED INSERTER INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD BARTLETT MFG NA MA08C030

    Patients

    Seq Age Sex Outcome Treatment
    1 SPACER