BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-10102

    MDR report key: 2961400 · Received February 11, 2013

    Report

    Report Number
    2520274-2013-10102
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    December 17, 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 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.

    Description of Event or Problem · 1

    PATIENT PARTICIPATED IN A (B)(6) 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 C5 C6 AND C6 C7 WITH PEDICLE SCREWS AT C5, C6 AND C7. PT HAD BEEN EXPERIENCING PAIN FOR 84 MONTHS. SURGERY DATE WAS (B)(6) 2007 AND POSTOPERATIVELY PT EXPERIENCED CHOCKING, REQUIRING OBSERVATION. THIS COMPLAINT IS ON THE RIGHT 16MM FIXED ANGLE SCREW AT C5. THIS IS REPORT 3 OF 7 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60052 KWQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1