BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-10338

    MDR report key: 2978530 · Received February 20, 2013

    Report

    Report Number
    2520274-2013-10338
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Report Date
    June 5, 2004
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    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 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. NO SAMPLE WAS RETURNED FOR EVAL. THE LOT NUMBER IS UNK; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN, AS SAMPLE WAS NOT RECEIVED.

    Description of Event or Problem · 1

    PT PARTICIPATED IN A MULTI-CENTER PROSPECTIVE STUDY FOR PTS WITH CERVICAL DDD WHO REQUIRE SINGLE OR MULTI-LEVEL ANTERIOR SPINAL FUSION WITH THE CSLP SMALL STATURE AND THE ACF SPACER PLUS DBX. PT WAS IMPLANTED AT LEVELS C3 C4 AND C4 C5 WITH A CSLP SMALL STATURE PLATE. PT HAD BEEN EXPERIENCING PAIN FOR 7 MONTHS. SURGERY DATE WAS (B)(6) 2003 AND POSTOPERATIVELY PT EXPERIENCED PAIN, REQUIRING PE AND STEROIDS. THIS REPORT IS 4 OF 7 FOR THS SAME EVENT. THIS COMPLAINT IS ON THE RIGHT SCREW AT C4 (12 MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74729 HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1