BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOS TAPER PIN 1 PIN 50X1.3

    MDR report key: 2391761 · Received December 29, 2011

    Report

    Report Number
    1818910-2011-27349
    Event Type
    Injury
    Date Received
    December 29, 2011
    Report Date
    November 9, 2011
    Manufacturer
    DEPUY FRANCE
    Product Code
    OVZ
    PMA / PMN Number
    K111077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES 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 AT THIS TIME. SHOULD THE PRODUCT AND / OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    PATIENT REVISED FOR PAIN AND REACTION TO ORTHOSORB PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOS TAPER PIN 1 PIN 50X1.3 TRAUMA OVZ DEPUY FRANCE 18110704

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention