BEUDAMED
    FDA Adverse Event Other Summary report: N

    LACTOSORB 1.5MM X SHAPE EXT PLATE

    MDR report key: 1294591 · Received January 21, 2009

    Report

    Report Number
    1032347-2009-00008
    Event Type
    Other
    Date Received
    January 21, 2009
    Date of Event
    November 19, 2008
    Report Date
    January 6, 2009
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL PLATES WERE NOT RETURNED, REVIEWED PICTURES TAKEN DURING REVISION SURGERY. IFU WARNS "IMPROPER SELECTION, PLACEMENT, POSITIONING, OR FIXATION OF THE IMPLANT CAN CAUSE A SUBSEQUENT UNDESIRABLE RESULT. THE SURGEON IS TO BE FAMILIAR WITH THE DEVICES, THE METHOD OF APPLICATION AND THE SURGICAL PROCEDURE PRIOR TO PERFORMING SURGERY." BASED ON THE SIZE OF THE DEFECT, THE NUMBER OF PLATES SELECTED WERE NOT ENOUGH TO FIXATE THE PT. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. SEE 1032347-2009-00009 FOR 2ND PLATE USED IN THE SAME SURGERY.

    Description of Event or Problem · 1

    LACTOSORB PLATES WERE IMPLANTED FOR RECONSTRUCTION OF CRANIAL DEFECTS, SIZE 11CM LONG AND 12CM WIDE. ON (B) (6)2008, NOTICED A CONCAVE SURFACE. ON (B) (6)2008, (ABOUT 3 WEEKS POST-OP) REVISION SURGERY WAS PERFORMED, FOUND 915-2413 WAS BROKEN IN TWO PIECES AND 915-2423 FOUND DEFORMED TOGETHER WITH BONE FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LACTOSORB 1.5MM X SHAPE EXT PLATE RESORBABLE PLATE MAI BIOMET MICROFIXATION 928390

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Hospitalization