BEUDAMED
    FDA Adverse Event Summary report: N

    LACTOSOR PLATES AND SCREWS

    MDR report key: 1970187 · Received January 25, 2011

    Report

    Report Number
    1032347-2011-00011
    Date Received
    January 25, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 26, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K955729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR; STATES "IMPLANTATION OF FOREIGN MATERIALS CAN RESULT IN AN INFLAMMATORY RESPONSE OR ALLERGIC REACTION." CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. THERE WERE 5 DIFFERENT PART NUMBER / LOT NUMBERS IMPLANTED IN THE PATIENT. AS THE IMPLANTS HAD ALREADY STARTED THEIR RESORBTION PROCESS, WE ARE UNABLE TO DETERMINE WHAT PRODUCT WAS EXPLANTED. BELOW IS THE LIST OF THE DEVICES IMPLANTED. PART NUMBER: 915-2315, LOT NUMBER: 777210, MANUFACTURED DATE: 1/21/2010, PRODUCT DESCRIPTION: LACTOSORB SCREW, 1.5X4MM; 915-2316, 993170, 3/2/2010, LACTOSORB SCREW, 1.5X5MM; 915-2413, 874530, 7/14/2009, LACTOSORB 1.5MM 4 HOLE STRAIGHT PLATE; 915-2427, 506040, 7/24/2009, LACTOSORB 1.5MM 6 HOLE CURVED PLATE; 915-2412, 630010, 12/2/2009, LACTOSORB PANEL, 50X50MM.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD SEVERAL LACTOSORB PLATES AND SCREWS IMPLANTED IN (B)(6) 2010 FOR A ZYGOMATIC FRACTURE. THE PATIENT SAW THE DOCTOR AGAIN ON (B)(6) 2010 BECAUSE THERE WAS SOMETHING SWOLLEN ON THE LOWER EYELID. THE DOCTOR FOUND GRANULOMA AND THE GRANULOMA ALONG WITH PIECES OF THE LACTOSORB IMPLANTS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LACTOSOR PLATES AND SCREWS RESORBABLE PLATE AND SCREWS HRS BIOMET MICROFIXATION SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization