BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 1636522 · Received March 19, 2010

    Report

    Report Number
    1030489-2010-00311
    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 INFORMATION. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A 13-LEVEL POSTERIOR SPINAL INSTRUMENTATION FOR IDIOPATHIC SCOLIOSIS USING HOOK AND CROSSLINK INSTRUMENTATION. THE PATIENT DID NOT HAVE AN ACUTE POSTOPERATIVE INFECTION OR ANY SIGNS OF AN IMPENDING POSTOPERATIVE INFECTION. TWENTY MONTHS POST-OP, THE PATIENT PRESENTED WITH DRAINAGE FROM NEAR THE CROSSLINK. THE PATIENT WAS DIAGNOSED WITH AN INFECTION. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE ALL OF THE POSTERIOR INSTRUMENTATION. THE WOUND WAS CLOSED IN TWO STAGES, THREE DAYS APART. AFTER INSTRUMENTATION REMOVAL, THE PATIENT WAS GIVEN CEFAZOLIN FOR 5 DAYS, AND CEPHALEXIN WAS GIVEN FOR 16 DAYS. ORGANISM GROWN FROM CULTURE WAS IDENTIFIED AS MICROCOCCUS VARIANS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention