BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-10472

    MDR report key: 2980438 · Received February 22, 2013

    Report

    Report Number
    2520274-2013-10472
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    January 11, 2007
    Product Code
    NKB
    Adverse Event
    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 02/2012. 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. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    PT PARTICIPATED IN A (B)(4) STUDY OF TREATMENT FOR 1 OR 2 LEVEL DEGENERATIVE DISC DISEASE BETWEEN L2 AND S1. PT WAS IMPLANTED WITH AN FRA SPACER AT LEVEL L4_L5 SIZE AND L5_S1 SIZE. PT WAS ALSO IMPLANTED WITH AN ATB PLATE AT SCREW_L4_L, SCREW_L4_R, SCREW_L5_L, SCREW_L5_R, SCREW_S1_L AND SCREW_S1_R, WITH ATB PLATED 449.082. PT HAD BEEN EXPERIENCING PAIN FOR 240 MONTHS. SURGERY DATE WAS (B)(6) 2007 AND POSTOPERATIVELY PT EXPERIENCED VASCULAR INJURY, REQUIRING REPAIR PRIMARILY WITH SUTURES. THIS COMPLAINT IS ON THE RIGHT SCREW AT S1 (24 MM). THIS COMPLAINT IS 2 OF 7 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77318 NKB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention