BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-10914

    MDR report key: 2986940 · Received February 26, 2013

    Report

    Report Number
    2520274-2013-10914
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Report Date
    July 27, 2004
    Manufacturer
    SYNTHES (USA)
    Product Code
    MNI
    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. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WERE PROVIDED.

    Description of Event or Problem · 1

    PATIENT PARTICIPATED IN A MULTI-CENTER PROSPECTIVE STUDY FOR PATIENTS WITH CERVICAL 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. PATIENT WAS IMPLANTED AT LEVELS C3 C4, C4 C5, C5 C6 AND C6 C7 WITH A CSLP SMALL STATURE PLATE. PATIENT HAD BEEN EXPERIENCING PAIN FOR 22 MONTHS. SURGERY DATE WAS (B)(6) 2004 AND POSTOPERATIVELY PATIENT EXPERIENCED DISTAL SCREWS MINIMALLY, REQUIRING NO TREATMENT. THIS IS REPORT 3 OF 11 FOR THIS EVENT. THIS REPORT IS ON THE LEFT SCREW AT C3 (14MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83201 MNI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1