BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 2182931 · Received July 28, 2011

    Report

    Report Number
    1030489-2011-00961
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 22, 2011
    Report Date
    August 17, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MAX
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED DEVICE FOUND THAT THE CAGE PRESENTS A CRACK STATING FROM ONE ENDPLATE AT THE NOSE NOT ENGRAVED WITH A "T" PROPAGATING THROUGH THE OPEN WINDOW. THE OPEN WINDOW AT THE NOSE NOT ENGRAVED WITH A "T" IS STILL FILLED WITH BONE GRAFT OR EQUIVALENT. THE RETURNED CAGE IS STILL FILLED WITH BONE GRAFT. IN ADDITION, THE CRACK ORIENTATION SUGGESTS THAT VERTICAL OVERLOAD HAS BEEN APPLIED TO THE CAGE. THIS MAY HAPPEN DURING THE BONE GRAFT IMPACTION INTO THE OPEN WINDOW OF THE CAGE ONCE THE IMPLANT HOLDER HOLD THE CAGE BY THE NOSE NOT ENGRAVED BY A "T" AND NOT IN THE PACKAGE AS DESCRIBED IN THE EVENT.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 9392507, 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 # 9392507, 510K # K094025 WAS CLEARED IN THE UNITED STATES. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE OR STAFF OPENED THE DEVICE, IT WAS DISCOVERED THAT THE DEVICE WAS BROKEN. THE ITEM WAS NOT USED WITH THE PATIENT.

    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 SY76

    Patients

    Seq Age Sex Outcome Treatment
    1