BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI VECTRA-T PLATE

    MDR report key: 2961342 · Received February 11, 2013

    Report

    Report Number
    8030965-2013-10064
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    December 29, 2007
    Manufacturer
    SYNTHES GMBH
    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

    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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PT PARTICIPATED IN A MULTI-CENTER, 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. PREOPERATIVE DIAGNOSIS WAS SYMPTOMS OF RADICULOPATHY. PT WAS IMPLANTED WITH A VECTRA-T CERVICAL PLATE AND A CC ACF SPACER AT LEVELS C3 C4, C4 C5, C5 C6, C6 C7 WITH PEDICLE SCREWS AT C3, C4, C5, C6 AND C7. PT HAD BEEN EXPERIENCING PAIN FOR 1 MONTH. SURGERY DATE WAS (B)(6) 2007 AND POSTOPERATIVELY PT EXPERIENCED WEAKNESS IN FINGERS, REQUIRING PT. THIS IS REPORT 1 OF 11 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60201 TI VECTRA-T PLATE KWQ SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1