BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-HANDLE WITH STRIKE PLATE

    MDR report key: 2276121 · Received September 29, 2011

    Report

    Report Number
    3005977257-2011-00004
    Event Type
    Malfunction
    Date Received
    September 29, 2011
    Date of Event
    August 29, 2011
    Report Date
    August 29, 2011
    Manufacturer
    SPINEFRONTIER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND TO MEET QUALITY REQUIREMENTS. DEVICE LABELING WAS REVIEWED AND IT WAS FOUND TO HAVE SUFFICIENT WARNING AND INSTRUCTION REGARDING PROPER USE OF STRIKE PLATE INSTRUMENTATION. IT HAS BEEN CONCLUDED THAT THE CONTRIBUTING FACTOR IN THE MALFUNCTION WAS THE MANNER IN WHICH THE PHYSICIAN USED THE DEVICE. DEVICE EVAL SUMMARY: THE T-HANDLE WITH STRIKE PLATE FROM THIS EVENT WAS RECEIVED ON (B)(4) 2011 AND SUBSEQUENTLY EVALUATED BY THE ENGINEERING AND QUALITY TEAMS. VISUAL EXAMINATION OF THE RETURNED T-HANDLE WITH STRIKE PLATE WAS CONDUCTED AND THE FOLLOWING WAS OBSERVED: THERE APPEARED TO BE MALLET INDENTATION ON THE UNDERSIDE OF THE DEVICE. THE STRIKE PLATE BROKE OFF STILL ATTACHED TO THE INTERNAL POST FEATURE. THIS SUGGESTS THAT THE UNDERSIDE OF THE DEVICE WAS STRUCK REPEATEDLY DAMAGING THE INTERNAL FEATURES THAT HOLD THE STRIKE PLATE IN PLACE. THE DAMAGE TO THE STRIKE PLATE AND THE T-HANDLE IS CONSISTENT WITH IMPROPER USE OF THE DEVICE.

    Description of Event or Problem · 1

    DURING AN S-LIF INTERBODY FUSION OF L3 TO L4, THE STRIKE PLATE OF A T-HANDLE BROKE OFF DURING USE. THE UNDERSIDE OF THE T-HANDLE WAS BEING STRUCK OF A MALLET IN ORDER TO REMOVE THE TRIAL IT WAS ATTACHED TO, WHEN THE STRIKE PLATE BROKE OFF. THERE WAS ONLY FIVE MINUTES ADDED TO SURGERY AND NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-HANDLE WITH STRIKE PLATE LXH SPINEFRONTIER, INC. SI50023 1446101A

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR