BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOSET

    MDR report key: 9012984 · Received September 12, 2019

    Report

    Report Number
    1043534-2019-00146
    Event Type
    Injury
    Date Received
    September 12, 2019
    Date of Event
    April 1, 2014
    Report Date
    August 16, 2019
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    MQV
    PMA / PMN Number
    K963587
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: VCELAK ET. AL. SURGICAL TREATMENT OF LUMBAR SPONDYLODISCITIS: A COMPARISON OF TWO METHODS. INTERNATIONAL ORTHOPAEDICS (SICOT) (2014) 38:1425-1434. PATIENT INFO: 20 MALE, 11 FEMALE, MEAN AGE 60.5 YEARS. 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

    IN A 2014 CLINICAL STUDY, VCELAK, ET AL. TITLED "SURGICAL TREATMENT OF LUMBAR SPONDYLODISCITIS: A COMPARISON OF TWO METHODS" GROUP A CONSISTING OF 23 PATIENTS WAS TREATED ONLY BY A DORSAL TRANSMUSCULAR APPROACH AND GROUP B CONSISTING OF EIGHT PATIENTS WAS TREATED BY TWO-STAGE POSTEROANTERIOR SURGERY. THE AUTHORS REPORTED TWO CASES OF SUPERFICIAL INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808148 OSTEOSET FILLER, BONE VOID, CALCIUM COMPOUND MQV WRIGHT MEDICAL TECHNOLOGY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention