BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE SYSTEM

    MDR report key: 1854151 · Received September 3, 2010

    Report

    Report Number
    1030489-2010-01119
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 7, 2010
    Report Date
    August 7, 2010
    Manufacturer
    SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MQP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 # 2991026, 510K # K073291 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 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 WHILE PLACING THE CAGE THE MIDDLE ASPECT FROM THE BACK OF THE IMPLANT CHIPPED OFF. THIS WAS COLLECTED IN A SPECIMEN POT AND WILL BE RETURNED. THE IMPLANT WAS LEFT IN PLACE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSTONE SYSTEM INTERBODY SPACER MQP SOFAMOR DANEK DEGGENDORF GMBH NA H10E1771

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other