BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT GOLD FRICTION-FIT 3. 5MM IMP

    MDR report key: 7391578 · Received April 3, 2018

    Report

    Report Number
    0001038806-2018-00347
    Event Type
    Malfunction
    Date Received
    April 3, 2018
    Report Date
    August 17, 2018
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    PK011028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER UNKNOWN / NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBERS K013227 / K953101.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR INSPECTION. NO DEVICE LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD REVIEW AND A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. THE COMPLAINANT INDICATED THAT THE ¿PATIENT COMPLAINED OF CROWN WOBBLING¿. THE COMPLAINT COULD NOT BE VERIFIED, AS THE ABUTMENT WAS NOT RETURNED AND THE EXACT DETAILS AND CONDITION OF DEVICE USAGE COULD NOT BE REPLICATED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HLA3G ABUTMENT LOOSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235200 ABUT GOLD FRICTION-FIT 3. 5MM IMP ABUTMENT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1