BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2020162 · Received March 7, 2011

    Report

    Report Number
    2520274-2011-00043
    Event Type
    Injury
    Date Received
    March 7, 2011
    Report Date
    February 4, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFO WAS NOT PROVIDED DURING INITIAL REPORT. ADD'L INFO HAS BEEN REQUESTED. PT SCHEDULED FOR REVISION SURGERY ON (B)(6) 2011. SYNTHES IS UNABLE TO DETERMINE MFG SITE OR MFG 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

    PT HAD AN ACCIDENT ON (B)(6) 2010, BROKE THE SAME ARM HE HAD BROKEN AND HAD SURGERY ON 19 YEARS PRIOR. SURGEON REMOVED PRE-EXISTING HARDWARE AND IMPLANTED TWO PLATES AND 18 SCREWS IN HIS ARM. POSTOP, ONE SCREW WAS NOTED TO BE BROKEN, THEN TWO MORE SCREWS WERE NOTED TO BE BROKEN. PT IS SCHEDULED FOR REVISION SURGERY ON (B)(6) 2011. THE BONE IS NOT GROWING TOGETHER AND THERE IS A GAP IN THE ARM OF 3MM. THIS IS THE 2ND OF 3 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 NI Required Intervention SCREWS