BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-10275

    MDR report key: 2976878 · Received February 19, 2013

    Report

    Report Number
    2520274-2013-10275
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Report Date
    March 15, 2004
    Manufacturer
    SYNTHES (USA)
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE (S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADD'L INFO 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

    PT PARTICIPATED IN A MULTI-CENTER PROSPECTIVE STUDY FOR PTS WITH CERVICAL DEGENERATIVE DISC DISEASE (DDD) WHO REQUIRE SINGLE OR MULTI-LEVEL ANTERIOR SPINAL FUSION WITH THE CSLP SMALL STATURE AND THE ACF SPACER PLUS DBX. PREOPERATIVE DIAGNOSIS WAS DISK FAILURE OR PROLAPSE. PT WAS IMPLANTED AT LEVELS C4 C5 WITH A CSLP SMALL STATURE PLATE. PT HAD BEEN EXPERIENCING PAIN FOR 2 MONTHS. SURGERY DATE WAS (B)(6) 2003 AND POSTOPERATIVELY PT EXPERIENCED PAIN, REQUIRING MEDS/PE/EMG NERVE CONDUCTION VELOCITY STUDY. THIS IS 3 REPORT OF 5 FOR THIS EVENT. THIS REPORT IS FOR THE LEFT SCREW AT C4 (12MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72872 NKB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1