BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT HEX-LOCK 4.5MM IMP 5 .5 FLARE

    MDR report key: 15331764 · Received August 31, 2022

    Report

    Report Number
    0002023141-2022-02273
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    June 23, 2021
    Report Date
    January 17, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024015210
    PMA / PMN Number
    K011028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PMA/510K: K013227, K953101.

    Additional Manufacturer Narrative · 0

    BASED ON UPDATED CUSTOMER INFORMATION RECEIVED AND REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT MFR REPORT NUMBER 0002023141-2022-02273 WAS REPORTED IN ERROR. PLEASE DISREGARD THIS SUBMISSION. NO FURTHER REPORTS WILL BE SUBMITTED FOR THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED ABUTMENT SCREW SLIP. 1 IMPLANT OF 4.7X8MM WAS IMPLANTED AT THE MISSING TOOTH SITE OF 19 ON (B)(6) 2020. THE ABUTMENT SCREW SLIP WAS FOUND ON (B)(6) 2021. THE CROWN AND THE ABUTMENT WERE REMOVED. THERE WAS NO IMPACT ON IMPLANT. OTHER ABUTMENT HAS BEEN USED TO COMPLETE THE SUBSEQUENT SURGERY.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2587972 ABUT HEX-LOCK 4.5MM IMP 5 .5 FLARE DENTAL ABUTMENT DZE ZIMMER DENTAL HLA4/5 2019050218 00889024015210

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male