BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-10921

    MDR report key: 2986990 · Received February 26, 2013

    Report

    Report Number
    2520274-2013-10921
    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 ADD'L INFO REC'D 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

    PT PARTICIPATED IN A MULTI-CENTER PROSPECTIVE STUDY FOR PT'S 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. PT WAS IMPLANTED AT LEVELS C3 C4, C4 C5, C5 C6 AND C6 C7 WITH A CSLP SMALL STATURE PLATE. PT HAD BEEN EXPERIENCING PAIN FOR 22 MONTHS. SURGERY DATE WAS (B)(6) 2004 AND POSTOPERATIVELY PT EXPERIENCED DISTAL SCREWS MINIMALLY, REQUIRING NO TREATMENT. THIS IS REPORT 10 OF 11 FOR THIS EVENT. THIS REPORT IS ON THE RIGHT SCREW AT C7 (14MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82800 MNI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1