BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 2217295 · Received August 19, 2011

    Report

    Report Number
    1030489-2011-01066
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MAX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE, PART # 9392507, 510K # K094025 WAS CLEARED IN THE UNITED STATES. THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR L4-5 TLIF WITH PEEK INTERBODY DEVICE. THE DEVICE CRACKED WHEN THE INSERTER WAS IMPACTED WITH A MALLET. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH TY98

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR