BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI VECTRA-T PLATE

    MDR report key: 2961431 · Received February 11, 2013

    Report

    Report Number
    2520274-2013-10162
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    March 28, 2011
    Manufacturer
    SYNTHES
    Product Code
    KWQ
    PMA / PMN Number
    K051665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. 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 ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    PT PARTICIPATED IN A (B)(4) 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. PREOPERATIVE DIAGNOSIS WAS AXIAL NECK PAIN. PT HAD BEEN EXPERIENCING PAIN FOR 18 MONTHS. PT WAS IMPLANTED WITH A VECTRA-T CERVICAL PLATE AND A CORTICO-CANCELLOUS ANTERIOR CERVICAL FUSION (CC ACF) SPACER AT LEVELS C6-C7 WITH PEDICLE SCREWS AT C6 AND C7. SURGERY DATE WAS (B)(6) 2007 AND POSTOPERATIVELY PT EXPERIENCED HOARSENESS AND CHOKING, REQUIRING OBSERVATION. THIS IS REPORT 1 OF 5 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59425 TI VECTRA-T PLATE KWQ SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1