BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-10306

    MDR report key: 2976884 · Received February 19, 2013

    Report

    Report Number
    2520274-2013-10306
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Report Date
    December 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 ADD'L INFO REC'D 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 REC'D.

    Description of Event or Problem · 1

    PT PARTICIPATED IN A MULTI-CENTER PROSPECTIVE STUDY FOR PT'S WITH CERVICAL DEGENERATIVE DISC 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. PT WAS IMPLANTED AT LEVELS C5 C6 AND C6 C7 WITH A CSLP SMALL STATURE PLATE. PT HAD BEEN EXPERIENCING PAIN FOR 36 MONTHS. SURGERY DATE WAS (B)(6) 2004 AND POSTOPERATIVELY PT EXPERIENCED NECK SPASMS REQUIRING PE. THIS REPORT IS 2 OF 7 FOR THE SAME EVENT. THIS COMPLAINT IS ON THE RIGHT SCREW AT C6 (14MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72873 HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1