BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL AMT COLLAR SIZE 8

    MDR report key: 2882379 · Received December 20, 2012

    Report

    Report Number
    1818910-2012-84039
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    July 11, 2012
    Report Date
    December 4, 2012
    Manufacturer
    DEPUY FRANCE S.A.S.-SAINT PRIEST
    Product Code
    KWA
    PMA / PMN Number
    PK042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. PER THE REPORTING BY THE DEPUY CLINICAL TEAM; ONLY PATIENT DEMOGRAPHICS ARE AVAILABLE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES A CALCAR CRACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL AMT COLLAR SIZE 8 STEM KWA DEPUY FRANCE S.A.S.-SAINT PRIEST 5113164

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention