BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACTO SORB SYSTEM 14MM RAPIDFLAP CLAMP

    MDR report key: 15978799 · Received December 14, 2022

    Report

    Report Number
    0001032347-2022-00386
    Event Type
    Malfunction
    Date Received
    December 14, 2022
    Date of Event
    October 20, 2021
    Report Date
    December 14, 2022
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    UDI-DI
    00841036053864
    PMA / PMN Number
    K003281
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). MEDICAL PRODUCTS: ITEM# 915-0020, LOT 610040; LACTO SORB SYSTEM 14MM RAPIDFLAP CLAMP. REPORT SOURCE: FOREIGN SOURCE: COLOMBIA. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2022-00388,

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE SCREWS FRACTURED DURING IMPLANTATION DURING A REVISION PROCEDURE. 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
    2141812 LACTO SORB SYSTEM 14MM RAPIDFLAP CLAMP PLATE, BONE JEY BIOMET MICROFIXATION N/A 032440 00841036053864

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female