BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEFT 16MM VARIABLE ANGLE SCREW

    MDR report key: 2993990 · Received February 27, 2013

    Report

    Report Number
    2520274-2013-10487
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    August 14, 2007
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED AND 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 (B)(4) 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO 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) 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. 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. POSTOPERATIVE, PT EXPERIENCED A STROKE, REQUIRING MEDICAL TREATMENT. THIS IS REPORT 2 OF 7 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83571 LEFT 16MM VARIABLE ANGLE SCREW KWQ SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention