BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYSTIQUE GCP

    MDR report key: 787076 · Received November 22, 2006

    Report

    Report Number
    2031733-2006-00018
    Event Type
    Injury
    Date Received
    November 22, 2006
    Date of Event
    October 12, 2006
    Report Date
    October 13, 2006
    Manufacturer
    MACROPORE BIOSURGERY
    Product Code
    NDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE REPORT #2031733-2006-00019 FOR SCREWS FROM SAME PT. RESULTS/CONCLUSIONS: NO LOT NUMBER WAS PROVIDED AND, THEREFORE, NO LOT HISTORY REVIEW COULD BE PERFORMED. THERE ARE NO MATERIAL OR MANUFACTURING DEFECTS PRESENT IN THE RETURNED PLATE. NO INFO WAS PROVIDED CONCERNING THE EVENTS, IF ANY, PRECEDING THE FAILURE OF THE PLATE. NO INFO WAS PROVIDED CONCERNING WHETHER THE PLATE WAS USED ACCORDING TO THE INSTRUCTIONS FOR USE PACKAGED WITH THE IMPLANTS (MACROPORE IFU IN4300), SPECIFICALLY WHETHER THE IMPLANTS WERE USED "...IN CONJUCTION WITH TRADITIONAL RIGID FIXATION..." THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE EXACT SEQUENCE LEADING TO OR THE ROOT CAUSE OF THE REPORTED EVENT. THE RETURNED PLATE SAMPLE IS IN THREE (3) PIECES. THE PLATE IS BROKEN INTO THREE PIECES FROM TWO CRACKS. THE FIRST CRACK RUNS FROM ONE EDGE OF THE PLATE, ACROSS THE WIDTH OF THE PLATE THROUGH THE TWO PRIMARY SCREW HOLE AND THE PRE-FIXATION HOLE (BETWEEN THE PRIMARY SCREW HOLES), AS SEEN TOP TO BOTTOM IN FIGURE 1. THE SECOND CRACK RUNS FROM ONE END OF THE PLATE, THROUGH THE RADIOPAQUE MARKER LOCATION (ROM HAS FALLEN OUT), AND CONTINUING TO THE PRE-FIXATION HOLE. THE ROM BEAD IN THE OPPOSITE END OF THE PLATE IS INTACT IN THE PLATE. EXAMINATION OF THE PRE-FIXATION PIN HOLE ON THE INTACT END OF THE PLATE SHOWS VERY SLIGHT SURFACE DAMAGE CONSISTENT WITH NORMAL, RECOMMENDED TECHNIQUE FOR PLACEMENT OF THE PLATE. DUE TO THE CRACKS ON THE OPPOSITE END OF THE PLATE, IT IS NOT POSSIBLE TO ASSESS THE PRE-FIXATION PIN HOLE ON THAT END OF THE PLATE. THE TWO PRIMARY SCREW HOLES ON THE CRACKED END OF THE PLATE, FROM WHICH THE SCREWS HAVE FALLEN OUT, HAVE BEEN TAPPED AND SHOW NO OTHER ABNORMAL FEATURES. THERE IS SURFACE DAMAGE TO THE PLATE, RUNNING DIAGONALLY ACROSS THE SURFACE. THE SURFACE DAMAGE DOES NOT APPEAR TO BE ASSOCIATED WITH THE BROKEN REGION OF THE PLATE. IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THIS DAMAGE, NOR WHEN THIS DAMAGE OCCURRED. IT WOULD SEEM LIKELY THAT THIS SURFACE DAMAGE OCCURRED DURING THE SURGERY TO REMOVE THE PLATE. EXAMINATION SHOWS NO MATERIAL OR MANUFACTURING DEFECTS TO BE PRESENT IN THE PLATE OR SCREWS. THE PLATE APPEARS TO HAVE GREATER CURVATURE IN THE SAGGITAL ORIENTATION THAN IS PROVIDED DURING MANUFACTURE. THIS CHANGE IN CONTOUR MAY HAVE BEEN DONE AT THE ORIGINAL SURGERY (PLATE CONTOURED IN HOT WATER BATH), OR MAY BE ASSOCIATED WITH THE PLATE BREAKAGE, OR WITH THE REMOVAL. CONCLUSIONS: THERE ARE NO MATERIAL OR MANUFACTURING DEFECTS PRESENT IN THE RETURNED PLATE OR SCREWS. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAILURE. NO INFO WAS PROVIDED CONCERNING THE EVENTS, IF ANY, PRECEDING THE FAILURE OF THE PLATE AND SCREWS. NO INFO WAS PROVIDED CONCERNING WHETHER THE PLATE AND SCREWS WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE PACKAGED WITH THE IMPLANTS (MACROPORE IFU IN43000), SPECIFICALLY WHETHER THE IMPLANTS WERE USED "...IN CONJUNCTION WITH TRADITIONAL RIGID FIXATION..." (IFU IN43000). IT IS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP OF THE OBSERVED PLATE CURVATURE OR SURFACE DAMAGE TO THE REPORTED EVENT. THEREFORE IT IS NOT POSSIBLE TO DETERMINE THE EXACT SEQUENCE LEADING TO OR THE ROOT CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IMPLANT DATE: 2006. IT WAS REPORTED THAT THE RESORBABLE PLATE WAS CRACKED AND ALL FOUR SCREWS WERE BROKEN. A REVISION SURGERY WAS DONE TO REMOVE THE IMPLANTS AND REPLACE WITH TITANIUM IMPLANTS. PLATE AND PARTS OF 4 SCREWS RETURNED TO MACROPORE FOR EVALUATION. NEITHER PART NUMBERS NOR LOT NUMBERS PROVIDED WITH THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYSTIQUE GCP SPINAL BONE FIXATION DEVICE NDJ MACROPORE BIOSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MYSTIQUE SCREWS, UNK PART NUMBER| (SEE REPORT #2031733-2006-00019)| UNK WHETHER RIGID FIXATION USED.