BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-10328

    MDR report key: 2978263 · Received February 19, 2013

    Report

    Report Number
    2520274-2013-10328
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    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 28 MONTHS. SURGERY DATE WAS (B)(6) 2003 AND POSTOPERATIVELY PATIENT EXPERIENCED CHRONIC SPRAIN/STRAIN CAP, REQUIRING MEDICATIONS/DECREASE WORK/LIFTING RESTRICTIONS. THIS REPORT IS 5 OF 5 FOR THE SAME EVENT. THIS COMPLAINT IS ON THE RIGHT SCREW AT C5 (12MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72686 HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1