BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT GOLD FRICTION-FIT 3. 5MM IMP

    MDR report key: 8121263 · Received November 30, 2018

    Report

    Report Number
    0002023141-2018-00938
    Event Type
    Malfunction
    Date Received
    November 30, 2018
    Date of Event
    July 1, 2018
    Report Date
    April 4, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K011028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WAS 1 ADDITIONAL RELATED COMPLAINT FOR THIS PRODUCT LOT. THIS ADDITIONAL COMPLAINT DESCRIBES SCREW LOOSENING, AND IS CONSIDERED A SIMILAR COMPLAINT. APPROPRIATE DOCUMENTATION WAS REVIEWED. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. WITHOUT THE RETURNED PRODUCT, THE EVENT AND THE ALLEGED DEVICE MALFUNCTION CANNOT BE VERIFIED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D3: MANUFACTURER. D4: DEVICE EXPIRATION IS N/A. D4: (B)(4). G2: MANUFACTURER'S CONTACT OFFICE. G4: DATE RECEIVED BY MANUFACTURER. G7: CHECKED "FOLLOW-UP" H2: CHECKED FOLLOW-UP TYPE. H3: CHANGED "NO" TO "YES". H4: DATE OF MANUFACTURE. H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE. THE FOLLOWING SECTIONS HAVE BEEN CORRECTED: A3: PATIENT'S GENDER. A4: PATIENT'S WEIGHT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT INFORMATION NOT PROVIDED/UNKNOWN. (B)(4). DEVICE STILL IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABUTMENT (HLA3G) LOOSENED. THE DOCTOR TIGHTENED THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958349 ABUT GOLD FRICTION-FIT 3. 5MM IMP ABUTMENT DZE ZIMMER DENTAL 2018032113

    Patients

    Seq Age Sex Outcome Treatment
    1