BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEG SMOOTH 2.0X18MM

    MDR report key: 1170014 · Received September 18, 2008

    Report

    Report Number
    1818910-2008-04066
    Event Type
    Injury
    Date Received
    September 18, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 26, 2008
    Manufacturer
    DEPUY ACE S.A. 'R.L.
    Product Code
    LXT
    PMA / PMN Number
    K050932
    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. THE INVESTIGATION WAS LIMITED TO THE INFO PROVIDED, AS THE LOT NUMBERS REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WERE NOT PROVIDED. PROVIDED INFO STATES DIDN'T USE LONG ENOUGH PEGS AT ORIGINAL SURGERY. PROVIDED INFO MARKED ON THE DEVICE EXPERIENCE REPORT IS MARKED THAT THE PRODUCTS ARE NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR CONTRIBUTING TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD THE PRODUCTS AND/OR ANY ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT REVISED TO ADDRESS PEGS USED AT PRIMARY WERE NOT LONG ENOUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEG SMOOTH 2.0X18MM 87LXT LXT DEPUY ACE S.A. 'R.L. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention