BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    END RING 12MM DIA/2.5 DEG (TI)

    MDR report key: 2954485 · Received February 11, 2013

    Report

    Report Number
    2520274-2013-00848
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    October 17, 2009
    Report Date
    October 20, 2009
    Manufacturer
    SYNTHES
    Product Code
    MQP
    PMA / PMN Number
    K003275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 2011. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    (B)(6) REPORTED THE LOWER RING WAS ASSOCIATED WITH THE SYNMESH. A 88MM SYNMESH C WAS CUT AND THE RINGS WERE PLACED AS PER THE SURGICAL TECHNIQUE BETWEEN C4 AND T2. THE CONSTRUCT WAS SUPPLEMENTED WITH POSTERIOR FIXATION TWO DAYS FOLLOWING THE ANTERIOR PROCEDURE. IT WAS NOTED DURING THE POSTERIOR PROCEDURE THAT THE ANTERIOR SYNMESH C CONSTRUCT HAD TILTED FORWARD AND REQUIRED REVISING. IN REVISING THE ANTERIOR SYNMESH C CONSTRUCT, IT WAS NOTED THAT THE LOWER RING (B)(4) HAD DISASSOCIATED FROM THE SYNMESH CAGE AND REMAINED EMBEDDED WITHIN THE VERTEBRA. THE SURGEON DID NOT WANT TO REMOVE THE END RING AS QUALITY OF THE PATIENT BONE WAS POOR, TUMOR, AND LEFT THE END RING IN-SITU, INSTEAD OPTING TO POSITION A NEW SYNMESH C BODY ON TOP OF THE END RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59306 END RING 12MM DIA/2.5 DEG (TI) END RING 12MM DIA/2.5 DEG (TI) MQP SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1