BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OASYS MIDLINE OCCIPUT PLATE- SMALL

    MDR report key: 2962429 · Received February 14, 2013

    Report

    Report Number
    0009617544-2013-00027
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 16, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    KWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, DEVICE HISTORY REVIEW, AND COMPLAINT HISTORY REVIEW. RESULTS: VISUAL INSPECTION: ONE PIN THAT CONNECTS A TULIP TO THE PLATE BODY IS BROKEN, THUS THE TULIP IS SEPARATED FROM THE PLATE. THE BREAKAGE IS OCCURRED AT THE NECK OF THE PIN JUST ABOVE THE ROUND HEAD. THE TULIP IS NOT DAMAGED. ON THE HEAD OF THE PIN THAT STUCK WITHIN THE TULIP ONE CAN SEE THE IMPRINT LEFT BY THE ROD DURING TIGHTENING. EXCEPT BROKEN TULIP AND SOME SCRATCHES, THE PLATE IS NOT DAMAGED. DEVICE HISTORY REVIEW: NO DEVIATION IN REGARDS WITH THE FAILURE MODE REPORTED WAS HIGHLIGHTED. THE CERTIFICATES OF RAW MATERIAL WERE IN ORDER. COMPLAINT HISTORY: THERE WERE 7 COMPLAINTS RECEIVED FOR POSTOPERATIVE BREAKAGE OF MIDLINE PLATE. CONCLUSION: THE REPORTED BREAKAGE WAS CONFIRMED AND A NON-CONFORMANCE AND CAPA REPORT HAS BEEN INITIATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SALES REP (B)(4) REPORTED ON BEHALF OF THE SURGEON, DR. (B)(6) THAT THE PLATE, WHICH HAD BEEN REVISED ON (B)(64) ((B)(4)) HAD BROKEN AGAIN. IT IS CURRENTLY STILL IMPLANTED."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SALES REP (B)(6) REPORTED ON BEHALF OF THE SURGEON, DR (B)(6), THAT THE PLATE, WHICH HAD BEEN REVISED ON (B)(6) (PLEASE SEE PER (B)(4)) HAD BROKEN AGAIN. IT IS CURRENTLY STILL IMPLANTED. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65757 OASYS MIDLINE OCCIPUT PLATE- SMALL OASYS MIDLINE OCCIPUT PLATE- SMALL KWP STRYKER SPINE-FRANCE 126452

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention