BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSORB LS 1.3MM 3 PIN KIT

    MDR report key: 5273572 · Received December 8, 2015

    Report

    Report Number
    0001825034-2015-04912
    Event Type
    Injury
    Date Received
    December 8, 2015
    Report Date
    November 19, 2015
    Manufacturer
    BIOMET TRAUMA
    Product Code
    OVZ
    PMA / PMN Number
    PK140625
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 3 STATES, ¿BENDING, FRACTURE, LOOSENING, RUBBING AND MIGRATION OF THE DEVICES CAN OCCUR AS A RESULT OF EXCESSIVE ACTIVITY, TRAUMA OR LOAD BEARING.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE HAS BEEN INDICATED DUE TO FRACTURING PINS; HOWEVER, NO REVISION HAS BEEN REPORTED AT THIS TIME. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805946 ORTHOSORB LS 1.3MM 3 PIN KIT PIN, FIXATION OVZ BIOMET TRAUMA N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R