BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI VECTRA(TM) PLATE 1 LEVEL/14MM

    MDR report key: 3070615 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-10962
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    June 6, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    KWQ
    PMA / PMN Number
    K050451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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 ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. MANUFACTURING SITE ADDRESS IS UNKNOWN. (B)(4). PLACEHOLDER.

    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 ADDITIONAL INFORMATION 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. PLACEHOLDER.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER DURING A 1-LEVEL ANTERIOR CERVICAL DISCECTOMY WITH FUSION (ACDF) PROCEDURE, THE SURGEON WAS IMPLANTING A VECTRA PLATE AND SCREWS. HE DECIDED TO CHANGE ONE OF THE SCREWS FOR A DIFFERENT SIZE SCREW. WHEN HE REMOVED THE SCREW, THE LOCKING CLIP IN THE PLATE HOLE BROKE. SURGEON REMOVED ALL 4 SCREWS, AND THE PLATE, AND REPLACED THEM WITH A NEW PLATE AND 4 NEW SCREWS. HE COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM. SCREWS WERE DISCARDED. THIS IS 1 OF 2 REPORTS FOR EVENT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172460 TI VECTRA(TM) PLATE 1 LEVEL/14MM KWQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1