BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZNN CMN NAIL 10MMX21.5CM 130R

    MDR report key: 2070315 · Received April 18, 2011

    Report

    Report Number
    9613350-2011-00233
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    January 17, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICES IN THE U.S. THE MANUFACTURER DID NOT YET RECEIVE 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. IT IS THEREFORE, NOT SUSPECTED THAT DEVICE FAILURE HAS LEAD TO THE ALLEGED EVENT. AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE AND/OR THE DEVICE(S) ARE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT IS AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT UNDERWENT REVISION 3 WEEKS AFTER INITIAL SURGERY SINCE THE LAG SCREW BACKED OUT OF THE NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZNN CMN NAIL 10MMX21.5CM 130R ZIMMER NATURAL NAIL HSB ZIMMER GMBH 2576108

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O