BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HINGE PEDIATRIC PLATING SYSTEM

    MDR report key: 2597672 · Received May 25, 2012

    Report

    Report Number
    3000327445-2012-00001
    Event Type
    Malfunction
    Date Received
    May 25, 2012
    Date of Event
    April 27, 2012
    Report Date
    May 25, 2012
    Manufacturer
    PEGA MEDICAL INC.
    Product Code
    HRS
    PMA / PMN Number
    K090440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO IS EXPECTED TO BE PROVIDED ONCE THE IMPLANT WILL BE REMOVED. X-RAYS OF THE FAILED IMPLANT AND PROBABLY THE IMPLANT ITSELF WILL BE AVAILABLE FOR ANALYSIS. SIZE AND LOT NUMBER OF THE IMPLANT HAS NOT BEEN YET PROVIDED BY THE USER.

    Description of Event or Problem · 1

    DR (B)(6) INFORMED PEGA MED BY PHONE THAT AN IMPLANTED HINGE PLATE HAS BROKEN AT THE LEVEL OF THE SEATING OF THE SCREWS. HE WILL HAVE TO RE-OPERATE THE PT IN ORDER TO REPLACE IT AS THE PT HAS NOT FINISHED CORRECTION. THERE IS NOT IMMINENT RISK TO THE PT BECAUSE THE GUIDED GROWTH CORRECTION MAY STILL CONTINUE OR AT THE WORST BE INACTIVE WHILE THE PT CONTINUES NORMAL GROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HINGE PEDIATRIC PLATING SYSTEM HINGE PLATE HRS PEGA MEDICAL INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NO CONCOMITANT MEDICAL PRODUCT KNOWN.