BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 1779170 · Received July 28, 2010

    Report

    Report Number
    1030489-2010-00974
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    June 9, 2010
    Report Date
    June 28, 2010
    Manufacturer
    SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MQP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 9393009, 510 # K094025 WAS CLEARED IN THE UNITED STATES. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT. 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 PT UNDERWENT AN UNSPECIFIED SPINAL PROCEDURE. AN UNK TIME POST-OP, THE PT WAS DIAGNOSED WITH AN INFECTION OF THE DISC SPACE. A REVISION SURGERY WAS CONDUCTED TO REMOVE THE INTERBODY DEVICE. NO OTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRESCENT SPINAL SYSTEM INTERBODY DEVICE MQP SOFAMOR DANEK DEGGENDORF GMBH NA PZ94

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention