BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-11008

    MDR report key: 3003504 · Received February 28, 2013

    Report

    Report Number
    2520274-2013-11008
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 8, 2007
    Report Date
    February 1, 2007
    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 REC'D REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. W/O 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 REC'D.

    Description of Event or Problem · 1

    THE 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 PT'S 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 WITH PEDICLE SCREWS AT C3, C4 AND C5. PT HAD BEEN EXPERIENCING PAIN FOR 12 MONTHS. SURGERY DATE WAS (B)(6) 2007 AND POSTOPERATIVELY PT EXPERIENCED SWALLOWING COMPLAINTS, REQUIRING NOTHING BUT TIME. THIS COMPLAINT IS ON THE LEFT 14MM FIXED ANGLE SCREW AT C3 AND THIS IS 7 OF 8 REPORTS FOR THE SAME STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86045 KWQ SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR