BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 2184061 · Received July 29, 2011

    Report

    Report Number
    1030489-2011-00968
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Report Date
    August 18, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
    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 # 7540000, PRODUCT CODE XXX WAS CLEARED IN THE UNITED STATES. (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 7540000, 510K # K031655 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

    EVALUATION OF THE RETURNED DEVICE FOUND THAT THE PEEK CAGE IS BROKEN NEAR THE MASSIVE SECTION OF THE NOSE ENGRAVED WITH A "T" (15 DEGREE OFFSET INSERTION). THE HANDLING FEATURE IS SHOWING WORN EDGE AT THE ANTERIOR SIDE OF THE CAGE. THESE DEFORMATIONS CAN BE ATTRIBUTED TO THE USE OF THE IMPLANT INSERTER TO IMPACT THE CAGE INTO THE INTERVERTEBRAL SPACE AND / OR TO REMOVE THE CAGE AFTER THE BREAKAGE OCCURRED. THE REMAINING MAIN PIECE OF THE CAGE WAS NOT RETURNED FOR ANALYSIS. THE OBSERVATION OF THE RETURNED IMPLANT DID NOT PERMIT TO IDENTIFY ANY DEFECT PRESENT PRIOR TO THE IMPLANTATION THAT WOULD BE RESPONSIBLE OF THE BREAKAGE. THE TYPE OF BREAKAGE IS CONSISTENT WITH AN OVER-LOADING OF THE PART DURING IMPACTION. THE ORIGIN OF THE OVER-LOADING WAS NOT DETERMINED. THE ANGULATION OF THE CAGE RELATIVE TO THE DISC SPACE DURING INSERTION CAN INFLUENCE THE LEVEL OF IMPACTION LOADS. ANOTHER FACTOR CAN BE THE SIZE OF THE CAGE CHOSEN COMPARED TO THE DISC PREPARATION AND DISTRACTION. BASED ON THE PRINT SPECIFICATIONS, THE PROBE/TRIAL AND THE CAGE HAVE THE SAME HEIGHT.

    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 THE INTERBODY DEVICE BROKE DURING IMPLANTATION. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRESCENT SPINAL SYSTEM MAX MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH NA TH64

    Patients

    Seq Age Sex Outcome Treatment
    1