BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI VECTRA-T PLATE

    MDR report key: 3003496 · Received February 28, 2013

    Report

    Report Number
    2520274-2013-10784
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    April 9, 2008
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADD'L INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. NO SAMPLE WAS RETURNED FOR EVAL. THE LOT NUMBER IS UNK THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN, AS SAMPLE WAS NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT PARTICIPATED IN A (B)(6), 4-ARM STUDY AT VERTEBRAL LEVELS 1, 2, 3 OR 4 TO EVALUATE THE CLINICAL AND RADIOGRAPHIC OUTCOMES IN PTS DIAGNOSED WITH CERVICAL DEGENERATIVE DISC DISEASE (DDD) BETWEEN C2-C7. PT WAS IMPLANTED WITH A VECTRA-T CERVICAL PLATE AND A CC ACF SPACER AT LEVELS C5 C6 AND C6 C7 WITH PEDICLE SCREWS AT C5, C6 AND C7. POSTOPERATIVELY PT EXPERIENCED DELAYED UNION C5-C6 AND C6-C7, REQUIRING OBSERVATION. THIS IS REPORT 2 OF 8 FOR THE SAME EVENT. THIS COMPLAINT IS FOR THE CC ACF SPACER SIZE 8 LORDOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86972 TI VECTRA-T PLATE KWQ SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1