BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRAIGHT PLATE 8 HOLE

    MDR report key: 1040112 · Received May 7, 2008

    Report

    Report Number
    1818910-2008-01640
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 28, 2008
    Manufacturer
    DEPUY ACE S.A. 'R.L.
    Product Code
    HRS
    PMA / PMN Number
    K905595
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. LE LOCLE REVIEWED THE DEVICE HISTORY RECORDS AND FOUND NO DISCREPANCIES. A SEARCH FOR THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD THE PRODUCT AND/OR ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    TWO MONTHS AFTER THE SURGERY, THE PLATE WAS FOUND BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRAIGHT PLATE 8 HOLE 87HRS HRS DEPUY ACE S.A. 'R.L. NA DFFBB1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention