BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-10168

    MDR report key: 2994059 · Received February 27, 2013

    Report

    Report Number
    2520274-2013-10168
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    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 MFG INVESTIGATION WAS CONDUCTED AS THERE WERE NO ISSUES WITH THE CMF PLATE OR THE SCREWS. W/O A CATALOG/PART AND LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN AS THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN AS THE DEVICE WAS NOT EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PRO-DISC-C IMPLANTS WERE IMPLANTED AT LEVEL C5/C6 AND C6/C7 ON AN UNK DATE. DURING THE PRODISC-C IMPLANT PROCEDURE, THE C6 VERTEBRAL BODY SPLIT WHICH AND THE SURGEON USED A LOW-PROFILE CMF PLATE AND 4 SCREWS TO SECURE THE BODY. THE PT EXPERIENCED INCREASED DISCOMFORT AND THE LATERAL X-RAY SHOWED MIGRATION ANTERIOR OF THE SUPERIOR LEVEL C5/C6 IMPLANT OVER THE INFERIOR LEVEL C6/C7. ON (B)(6) 2011 THE SURGEON REMOVED ALL DEVICES, NOTED THE SPLIT HEALED WITH THE LOW-PROFILE CMF PLATE AND SCREWS, AND REVISED THE PT TO A PLATE WITH TWO ALLOGRAFT SPACES. THIS IS REPORT IS FOR ONE SCREW AND IS REPORT 5 OF 7 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83815 HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention