BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LACTO SCR 1.5X3MM 1.5 SYS 2PK

    MDR report key: 3607398 · Received February 5, 2014

    Report

    Report Number
    0001032347-2014-00022
    Event Type
    Injury
    Date Received
    February 5, 2014
    Date of Event
    December 17, 2013
    Report Date
    January 22, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    PK012409
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE NHB. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THERE WAS NO PRODUCT RETURNED FOR EVALUATION AS IT WAS USED IN INFECTION CONTROL TESTING; THEREFORE, NO PRODUCT WILL BE REVIEWED BY THE MANUFACTURER. 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.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED A LACTOSORB REVISION SURGERY DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75431 LACTO SCR 1.5X3MM 1.5 SYS 2PK RESORBABLE BONE SCREW HWC BIOMET MICROFIXATION N/A 705270

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization