BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSORB ABSORBABLE

    MDR report key: 54261 · Received December 10, 1996

    Report

    Report Number
    1219655-1996-00045
    Event Type
    Injury
    Date Received
    December 10, 1996
    Date of Event
    September 11, 1996
    Report Date
    December 10, 1996
    Manufacturer
    JOHNSON & JOHNSON PROFESSIONAL, INC.
    Product Code
    MBJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CO RECEIVED MEDWATCH REPORT NO. 1010284 FROM THE FOOD & DRUG ADMIN CONCERNING AN ABSORBABLE PIN. ACCORDING TO THE REPORT "DEVICE WAS USED TO STABILIZE A BONE. PT WAS SUFFERING FROM CONTINUOUS SWELLING. X-RAYS WERE TAKEN AND IT REVEALED EXTREME RESORPTION OF METATARSAL HEAD SECONDARY TO THE USER OF THE DEVICE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOSORB ABSORBABLE Implant ABSORBABLE PIN MBJ JOHNSON & JOHNSON PROFESSIONAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other