BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACTO 14MM RAPIDFLAP CLAMP

    MDR report key: 12860800 · Received November 23, 2021

    Report

    Report Number
    0001032347-2021-00540
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    May 10, 2021
    Report Date
    November 22, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    UDI-DI
    0084103605386
    PMA / PMN Number
    K003281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). LACTO 14MM RAPIDFLAP CLAMP CAT# 915-0020 LOT# 059540 THE DEVICE WAS REPORTED TO BE DISASSEMBLED DURING USAGE. UPON VISUAL EXAMINATION OF THE PROVIDED PICTURES, THE DEVICE WAS FOUND TO BE FRACTURED. THE PART AND LOT INFORMATION WAS VERIFIED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2021-00269

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS DISASSEMBLED DURING USAGE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758925 LACTO 14MM RAPIDFLAP CLAMP CRANIOFACIAL FIXATION PLATE, BIOABSORBABLE JEY BIOMET MICROFIXATION NI 059540 0084103605386

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male