BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW CORTICAL 3.5 X 16MM

    MDR report key: 1021295 · Received March 28, 2008

    Report

    Report Number
    1818910-2008-00911
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 6, 2008
    Manufacturer
    DEPUY ACE S.A. R.L.
    Product Code
    HWC
    PMA / PMN Number
    K905048
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR ALL REPORTED PART AND LOT NUMBER COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT. PROVIDED INFORMATION MARKED ON THE DEVICE EXPERIENCE REPORT IS MARKED THAT THE PRODUCTS ARE NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. 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

    PATIENT WAS REVISED TO ADDRESS A COMPLAINT OF PAINFUL HARDWARE (LEFT SIDE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW CORTICAL 3.5 X 16MM 87HWC HWC DEPUY ACE S.A. R.L. NA DFH3MK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention