BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI ARCOFIX PF PLATE

    MDR report key: 1900129 · Received November 10, 2010

    Report

    Report Number
    1719045-2010-00324
    Event Type
    Injury
    Date Received
    November 10, 2010
    Report Date
    October 12, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWQ
    PMA / PMN Number
    K080020
    Removal / Correction Number
    PENDING
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. INVESTIGATION IS ONGOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PT SUFFERED A BURST FRACTURE TRAUMA (B)(6) 2008 AND IS IN A WHEEL CHAIR AS A RESULT OF THE TRAUMA. PT INSTRUMENTED AT T12 WITH ARCOFIX AND SYNEX II. SURGEON USED PT'S BONE TO PACK INSIDE AND AROUND THE CAGE. X-RAYS TAKEN (B)(6) 2008 WERE UNEVENTFUL. APPROXIMATELY (B)(6)2010, PT REPORTEDLY HEARD A SQUEAKING NOISE AND EXPERIENCED PAIN. X-RAYS TAKEN AT THAT TIME SHOWED THE SUPERIOR ENDPLATE OF SYNEX II TO BE TILTED ANTERIORLY AND ARCOFIX PLATE APPEARED TO HAVE REDUCED IN HEIGHT. SYNEX II SHOWED BREAKAGE AT THE CENTRAL CORE. PT WAS CLOSELY MONITORED AND REVISED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI ARCOFIX PF PLATE ARCOFIX PF PLATE KWQ SYNTHES MONUMENT NA 1900296

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention SCREWS| SYNEX II