BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2032584 · Received March 23, 2011

    Report

    Report Number
    2520274-2011-00076
    Event Type
    Injury
    Date Received
    March 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING SITE OR MANUFACTURING DATE WITHOUT A LOT NUMBER. SYNTHES IS UNABLE TO DETERMINE 510(K) # WITHOUT A PART NUMBER OR LOT NUMBER. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    ACDF AT C5-C7 WAS PERFORMED ON AN UNK DATE. SURGEON PLACED 2 BONE DOWELS BETWEEN C5-C6 & C6-C7 AND ADDED CERVICAL SPINE LOCKING PLATE AT C5-C7. STATUS POST, PT COMPLAINED OF RADICULAR PAIN. FOLLOW-UP VISIT X-RAYS CONFIRMED NON-UNION AT C6-C7. PT REVISED ON (B)(6) 2011. BOTH BONE DOWELS AND THE CSLP PLATE WERE REMOVED. NEW PLATE AND NEW BONE DOWELS WERE PLACED AT C6-C7. PT FLIPPED TO PRONE POSITION. AXON INSTRUMENTATION PLACED OFF LABEL IN POSTERIOR LATERAL MASSES FROM C5-C7. HARDWARE REMOVED WAS DISCARDED. SURGEON NOTED THAT THE EXPLANTED HARDWARE WAS NOT DAMAGED OR BROKEN. NO REPORTED ISSUE WITH HARDWARE. THIS IS THE 2ND OF 2 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI SCREW HWC SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention PLATE| SCREWS| BONE DOWELS