BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCB DF PLATE, LEFT, 9 HOLES

    MDR report key: 2901183 · Received January 4, 2013

    Report

    Report Number
    9613350-2013-01220
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 21, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT YET RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE REC'D FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THERE IS NO INDICATION FOR A PRODUCT FAILURE. WITH THE INFO GIVEN TO FAR, NO FURTHER INVESTIGATION IS POSSIBLE. THE ROOT CAUSE FOR THIS EVENT CANNOT BE IDENTIFIED. SHOULD ADD'L INFO BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AND AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    THE PT REPORTS PAIN AND THE DOCTOR CONFIRMED THAT NCB WAS BROKEN. THE PT HAD TO UNDERGO A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4524 NCB DF PLATE, LEFT, 9 HOLES NCB PLATING SYSTEM HRS ZIMMER GMBH 2626085

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R