BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACTOSORB PLATES

    MDR report key: 1026453 · Received April 7, 2008

    Report

    Report Number
    1032347-2008-00011
    Event Type
    Malfunction
    Date Received
    April 7, 2008
    Date of Event
    January 11, 2008
    Report Date
    January 11, 2008
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    K980927
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER PRODUCT ALSO MAY HAVE SAME ISSUE: (LOT 898330), (898250), (898350), (898320), (951140), (868920) & (978810). THIS WAS INVESTIGATED UNDER THE RECALL. WE KNOW OF AT LEAST 1 PIECE THAT HAS BEEN IMPLANTED (DATE UNKNOWN). THERE HAVE BEEN NO REPORTS OF COMPLICATIONS FOR THIS PIECE.

    Description of Event or Problem · 1

    OUTER POUCH OF A DOUBLE POUCHED PRODUCT, WAS NOT COMPLETELY SEALED. PRODUCT IS SOLD AS STERILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LACTOSORB PLATES RESORBABLE PLATES JEY BIOMET MICROFIXATION 898240

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREWS WOULD BE USED TO FIXATE THE PLATE. UNKNOWN| WHICH OR HOW MANY SCREWS WOULD BE USED.