BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-10321

    MDR report key: 2978241 · Received February 19, 2013

    Report

    Report Number
    2520274-2013-10321
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Report Date
    October 7, 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 FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO SAMPLE WAS RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN 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

    PATIENT PARTICIPATED IN A MULTI-CENTER PROSPECTIVE STUDY FOR PATIENTS WITH CERVICAL DEGENERATIVE DISK DISEASE 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 C5 C6 WITH A CSLP SMALL STATURE PLATE. PATIENT HAD BEEN EXPERIENCING PAIN FOR 120 MONTHS. SURGERY DATE WAS (B)(6) 2003 AND POSTOPERATIVELY PATIENT EXPERIENCED PAIN, REQUIRING PE. THIS REPORT IS 3 OF 5 FOR THE SAME EVENT. THIS COMPLAINT IS ON THE LEFT SCREW AT C6 (12MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72460 HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1