BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 2220431 · Received August 23, 2011

    Report

    Report Number
    1030489-2011-01086
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 27, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    MAX
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 2991232, PRODUCT CODE MAX WAS CLEARED IN THE UNITED STATES. (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 2991232, 510K # K073291 WAS CLEARED IN THE UNITED STATES. EVALUATION OF THE RETURNED DEVICE FOUND THAT THE CAGE PRESENTS SYMMETRIC CRACK AT THE JUNCTION WITH THE IMPLANT INSERTER, SUSPECTING A LOAD HAS BEEN APPLIED IN THE UPPER OR LOWER VERTEBRA DIRECTION DURING THE INSERTION OF THE CAGE. THE RETURNED CAGE WAS FOUND BROKEN AT THE LEVEL OF THE ATTACHMENT WITH THE IMPLANT INSERTER. NO PRE-EXISTING DEFECT WAS FOUND AT THE LEVEL OF THE BREAKAGE. THE BREAKAGE IS CONSISTENT WITH AN OVER-LOADING OF THE PART. THE ORIGIN OF THE OVER-LOADING CAN BE ATTRIBUTED TO THE APPLICATION OF AN LATERAL UP OR DOWN LOAD ON THE IMPLANT INSERTER IN CONJUNCTION WITH A ROTATION ALONG THE CAGE AXIS DURING THE IMPLANTATION OF THE CAGE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERBODY DEVICE BROKE WHILE IMPLANTING INTO S1-L5-L4 WITH "MILD HAMMERING." THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER PRODUCT. NO ADDITIONAL COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSTONE SPINAL SYSTEM MAX MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H10A0960

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR