BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYER ELEVATOR #40L

    MDR report key: 9081767 · Received September 18, 2019

    Report

    Report Number
    0001032347-2019-00416
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Report Date
    November 22, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EMJ
    UDI-DI
    00841036028428
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE COMPLAINT IS NON-VERIFIABLE. THE CRYER ELEVATOR #40L (PART# 09-0289, LOT# 042516D16) WAS NOT RETURNED FOR INVESTIGATION AND NO PHOTOS WERE PROVIDED. FOR THESE REASONS, NO VISUAL EVALUATION OR FUNCTIONAL TESTING COULD BE CONDUCTED. THE DHR FOR THIS PRODUCT WAS REVIEWED, NO NON-CONFORMANCES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS THE ONLY COMPLAINT REGARDING THE TIP FRACTURING FOR THIS PART# 09-0289, LOT# 042516D16. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT COULD NOT 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.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT FRACTURED DURING STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875486 CRYER ELEVATOR #40L ELEVATOR, SURGICAL, DENTAL EMJ BIOMET MICROFIXATION N/A 042516D16 00841036028428

    Patients

    Seq Age Sex Outcome Treatment
    1