BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM

    MDR report key: 14603283 · Received June 6, 2022

    Report

    Report Number
    0002023141-2022-01403
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    May 18, 2022
    Report Date
    June 16, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020092
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PMA/510K: K011028, K013227.

    Additional Manufacturer Narrative · 0

    BASED ON UPDATED CUSTOMER INFORMATION RECEIVED AND REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT MFR REPORT NUMBER 0002023141-2022-01403 WAS REPORTED IN ERROR. PLEASE DISREGARD THIS SUBMISSION. NO FURTHER REPORTS WILL BE SUBMITTED FOR THIS EVENT. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G6: CHECKED "FOLLOW-UP".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEALING ABUTMENT DID NOT SEAT ALL THE WAY ON THE IMPLANT AND THEY BELIEVE THE IMPLANT MAY HAVE DAMAGED THREADS.

    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
    197242 IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWH10 63893935 00889024020092

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose