BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CLAVICLE PIN

    MDR report key: 2060657 · Received April 6, 2011

    Report

    Report Number
    1818910-2011-05985
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    April 17, 2009
    Report Date
    March 7, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS UNAVAILABLE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD 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

    LITIGATION ALLEGES THAT DURING THE WEEKEND PRIOR TO (B)(6) 2009, PATIENT NOTICED A BUMP DEVELOPING WHERE HIS CLAVICLE SCAR IS LOCATED AND INCREASED PRESSURE IN THE AREA AROUND HIS CLAVICLE SCAR. BETWEEN (B)(6) 2009, AND (B)(6) 2009, THE CLAVICLE ROD OR PIN INSERTED INTO PATIENT'S SHOULDER FRACTURED. ON (B)(6) 2009, PATIENT FIRST LEARNED THAT THE CLAVICLE ROD OR PIN INSERTED INTO HIS SHOULDER WAS BROKEN AFTER HE WAS TOLD THE RESULTS OF AN X-RAY OF HIS SHOULDER. ON (B)(6) 2009, THE DISTAL PORTION OF THE ROD OR PIN WAS SURGICALLY REMOVED FROM PATIENT'S CLAVICLE. IT IS ALSO ALLEGED THE PATIENT SUFFERED THE FOLLOWING DAMAGES: PERMANENT PHYSICAL INJURIES, IMPAIRMENTS, LOSS OF BODILY USE AND FUNCTION, AND DISABILITIES; PAIN AND SUFFERING, INCLUDING, BUT NOT LIMITED TO PAIN AND SUFFERING ASSOCIATED WITH ADDITIONAL SURGERIES; AND MEDICAL EXPENSES. DOI: (B)(6) 2009 - DOR: (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN CLAVICLE PIN NONE JDW DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention