BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZFX TI-SCREW-3I-CE-SCTIUN-3.4-6.0

    MDR report key: 8634037 · Received May 22, 2019

    Report

    Report Number
    0001038806-2019-00446
    Event Type
    Injury
    Date Received
    May 22, 2019
    Report Date
    June 13, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    HWC
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: IT WAS REPORTED THAT A ZFX GMBH SCREW FRACTURED WITHIN A BIOMET IMPLANT. THE IMPLANT WAS REMOVED. THERE IS NO REPORT OF PATIENT INJURY. CORRECTION: NO 03 JUNE 2019 FOLLOW UP SERIOUS INJURY ADDITIONAL INFORMATION METHOD, DEVICE, CONCLUSION CODES MANUFACTURER NARRATIVE, CORRECTED DATA INVESTIGATION OF THE REPORTED DEVICE IS THE RESPONSIBILITY OF THE SUPPLIER. DUE DILIGENCE HAS BEEN COMPLETED TO OBTAIN INVESTIGATION RESULTS BY THE SUPPLIER AND RESULTS HAVE NOT BEEN RECEIVED TO DATE. 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

    IT WAS REPORTED THAT A ZFX GMBH SCREW FRACTURED WITHIN A BIOMET IMPLANT. THE IMPLANT WAS REMOVED. THERE IS NO REPORT OF PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO REPORT (B)(4). THE REPORTED DEVICE HAS BEEN RECEIVED FOR INVESTIGATION. ONCE INVESTIGATION HAS BEEN COMPLETED. A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW FRACTURED WITHIN THE IMPLANT. THE IMPLANT WAS REMOVED. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427910 ZFX TI-SCREW-3I-CE-SCTIUN-3.4-6.0 TITANIUM SCREW HWC ZIMMER DENTAL N/A 000170320

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention