BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANT

    MDR report key: 1639894 · Received March 23, 2010

    Report

    Report Number
    1030489-2010-00354
    Event Type
    Injury
    Date Received
    March 23, 2010
    Date of Event
    January 19, 2010
    Report Date
    February 22, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    MQP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). LITERATURE ARTICLE CITATION: RAJ K SHAH ET AL. RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN 2-INDUCED HETEROTOPIC OSSIFICATION OF THE RETROPERITONEUM, PSOAS MUSCLE, PELVIS AND ABDOMINAL WALL FOLLOWING LUMBAR SPINAL FUSION. SKELETAL RADIOLOGY; DOI 10.1007/S00256-010-0890-8. 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 ANTERIOR LUMBAR DISCECTOMY OF L4-L5 AND L5-S1 WITH CORPECTOMY OF L5 USING A LEFT-SIDED PARAMEDIAN RETROPERITONEAL APPROACH. POSTERIOR SPINAL INSTRUMENTATION WAS PERFORMED BILATERALLY FROM L4-S1, A CAGE WAS PLACED, AND RHBMP-2/ACS WAS USED. THERE WAS A SIGNIFICANT AMOUNT OF BLEEDING FROM THE TUMOR AND VERTEBRAL BODY AND EPIDURAL BLEEDING DURING THE CORPECTOMY AND DECOMPRESSION OF THE L5 NERVE ROOT. THERE WAS PERSISTENT OOZING OF BLOOD, EVENT AT THE END OF THE CASE. FIVE DAYS POST-OP, X-RAYS REVEALED THAT THE CAGE AT L4-L5 MAY HAVE MIGRATED. THE PT UNDERWENT A REVISION SURGERY TO REPLACE AND REPOSITION THE CAGE. THE PT RECOVERED UNEVENTFULLY, WITH NO IMMEDIATE POST-OPERATIVE COMPLICATIONS, AND WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN IMPLANT CAGE MQP MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention INFUSE BONE GRAFT LARGE KIT| SEXTANT PEDICLE SCREW INSTRUMENTATION