BEUDAMED
    FDA Adverse Event Other Summary report: N

    LACTOSORB SCREW 1.5X4MM 1.5 SYSTEM, 10 PACK

    MDR report key: 1051794 · Received May 28, 2008

    Report

    Report Number
    1032347-2008-00021
    Event Type
    Other
    Date Received
    May 28, 2008
    Date of Event
    August 31, 2007
    Report Date
    May 2, 2008
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    MAI
    PMA / PMN Number
    K955729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFO 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. 1032347-2008-00019, 00020 & 00021 ARE ALL FOR THE SAME SURGERY.

    Description of Event or Problem · 1

    PT HAD SEVERAL RESORBABLE PLATES & SCREWS IMPLANTED, ALONG WITH TITANIUM PLATES & SCREWS IN 2007. PT CAME TO ER IN TWO MONTHS LATER AND THE FOLLOWING MONTH, FOR INFECTION. SOME OF THE RESORBABLE PLATES WERE REMOVED THE SAME MONTH, AND THE REMAINING RESORBABLE PLATES WERE REMOVED IN 2007 (EXACT DATE IN NOVEMBER NOT KNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LACTOSORB SCREW 1.5X4MM 1.5 SYSTEM, 10 PACK RESORBABLE SCREW MAI BIOMET MICROFIXATION 253190

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization WERE USED.| SEVERAL PLATES & SCREWS (RESORBABLE & TITANIUM)