BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PYRAMESH IMPLANT SYSTEM

    MDR report key: 1830988 · Received September 7, 2010

    Report

    Report Number
    1030489-2010-01160
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    March 14, 2005
    Report Date
    August 16, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    MQP
    PMA / PMN Number
    K923419
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LITERATURE CITATION: SHIELDS ET AL. ADVERSE EFFECTS ASSOCIATED WITH HIGH-DOSE RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 USE IN ANTERIOR CERVICAL SPINE FUSION. SPINE. 2006; 31: NUMBER 5, PP 542-547. DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WITHOUT ADDITIONAL DEVICE INFORMATION, A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT POSSIBLE. WE ARE THEREFORE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A 2-LEVEL VERTEBRECTOMY, AUGMENTED WITH HIGH-DOSE RHBMP-2/ACS. AT THE COMPLETION OF THE DECOMPRESSION IN THE ANTERIOR CERVICAL VERTEBRECTOMY AND FUSIONS, THE FORAMINA WERE OPENED BILATERALLY, A CAGE WAS APPROPRIATELY SIZED, CUT, CONTOURED, AND PACKED WITH A COMBINATION OF LOCAL BONE AND RHBMP-2. ADDITIONAL RHBMP-2 WAS PACKED ANTERIOR AND LATERAL TO THE CAGE. A CERVICAL PLATE WAS THEN PLACED. RADIOGRAPHS CONFIRMED APPROPRIATE POSITIONING OF THE PLATE AND CAGE. SOMETIME POSTOPERATIVELY CAGE DISLODGEMENT OCCURRED. THE REPORTER INDICATED THAT THE IMPLANT DISLODGEMENT DID NOT APPEAR TO BE RELATED TO THE USE OF THE RHBMP-2. THERE WERE NO OTHER COMPLICATIONS ASSOCIATED WITH THIS PATIENT. NO OTHER DETAILS OR OUTCOMES WERE MENTIONED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention