BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 1636543 · Received March 19, 2010

    Report

    Report Number
    1030489-2010-00297
    Event Type
    Injury
    Date Received
    March 19, 2010
    Date of Event
    March 29, 2001
    Report Date
    February 19, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). LITERATURE ARTICLE CITATION: RICHARDS ET AL, DELAYED INFECTIONS AFTER POSTERIOR TSRH SPINAL INSTRUMENTATION FOR IDIOPATHIC SCOLIOSIS. SPINE 2001; 26:18: 1990-1996. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFO. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A 12-LEVEL POSTERIOR SPINAL INSTRUMENTATION FOR IDIOPATHIC SCOLIOSIS USING HOOK AND CROSSLINK INSTRUMENTATION. THE PT DID NOT HAVE AN ACUTE POSTOPERATIVE INFECTION OR ANY SIGNS OF AN IMPENDING POSTOPERATIVE INFECTION. EIGHTEEN MONTHS POST-OP, THE PT PRESENTED WITH PAIN AND FEVER. THE PT WAS DIAGNOSED WITH AN INFECTION. THE PT UNDERWENT A REVISION SURGERY TO REMOVE ALL OF THE POSTERIOR INSTRUMENTATION. THE WOUND WAS CLOSED IN ONE STAGE. AFTER INSTRUMENTATION REMOVAL, THE PT WAS GIVEN CEFAZOLIN FOR 4 DAYS AND CEPHALEXIN FOR 14 DAYS. CULTURES TAKEN HAD NO GROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRH SPINAL SYSTEM HOOK, RODS, SCREWS KWQ MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention