BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZNN CMN LAG SCREW 10.5X105

    MDR report key: 2090936 · Received May 2, 2011

    Report

    Report Number
    9613350-2011-00282
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    February 21, 2011
    Report Date
    April 7, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICES IN (B)(4). THE MANUFACTURER HAS NOT YET RECEIVED THE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED AS SOON AS FURTHER INFO COME IN OR AN INVESTIGATION RESULT IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT HAD CM NAIL IMPLANTED TO REPAIR INTERTROCH FX. IT IS ALSO REPORTED THAT NO HEALING OCCURRED AND THE FEMORAL NECK/HEAD DELL INTO VARUS. THERE WAS NO CUT OUT OF MIGRATION OF THE LAG SCREW. PT WAS REVISED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZNN CMN LAG SCREW 10.5X105 ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDU HSB ZIMMER GMBH 2522360

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization