BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HWC

    MDR report key: 2949984 · Received February 6, 2013

    Report

    Report Number
    2520274-2013-10109
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    March 21, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 FEB 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. WITHOUT A PART OR LOT # THE DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. THE PART EVAL COULD NOT BE PERFORMED AND NO CONCLUSION DETERMINED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGEON REMOVED ONE ZERO-P IMPLANT AND FOUR LOCKING SCREWS FROM THE PT DUE TO NON-FUSION. PT WAS REVISED TO A CERVICAL SPACER. EXPLANTED HARDWARE WAS DISCARDED BY THE HOSP. SEE MFR REPORT 1 OF 5 #1719045-2010-00294. THIS IS 2 OF 5 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51335 HWC HWC SYNTHES (USA) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention