BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.1MM,SBM,11.5

    MDR report key: 12347252 · Received August 20, 2021

    Report

    Report Number
    0002023141-2021-02229
    Event Type
    Malfunction
    Date Received
    August 20, 2021
    Date of Event
    July 19, 2021
    Report Date
    December 22, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019232
    PMA / PMN Number
    K072589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE TAPERED SCREW VENT (TSV4B11-BUNDLED ITEM) WITH FRACTURE MOUNT HEX AND FRACTURE SCREW WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED IMPLANT MOUNT HEX AND SCREW FRACTURED. PART OF SCREW STILL REMAINED INSIDE IMPLANT. IMPLANT HAS SOME DAMAGES BUT ITS MOST LIKELY DUE TO REMOVAL PROCESS. PRE-EXISTING CONDITION AS NOTED ON THE PER IS TYPE I (HIGH) BONE DENSITY. THE DEVICE WAS LOCATED ON TOOTH SITE #29 (UNIVERSAL) AND THE EVENT OCCURRED DURING PLACEMENT PROCEDURE. THE REPORTED EVENT COULD NOT BE RECREATED DUE TO THE NATURE OF THE DENTAL DEVICE AND EVENT (FRACTURE). X-RAY OR PICTURE IMAGE WAS NOT PROVIDED BY CUSTOMER. DHR REVIEW: THE DHR WAS NOT AVAILABLE ELECTRONICALLY FOR THE SUBJECT LOT NUMBER (1242834). THEREFORE, IT COULD NOT BE FURTHER REVIEWED AT THE TIME OF THE INVESTIGATION. A NOTIFICATION HAS BEEN SENT TO MANUFACTURING TO REQUEST THE DHR FOR REVIEW. THE PCE WILL BE REOPENED AND UPDATED IF THERE IS ANY INDICATION OF NONCONFORMANCE, OR ANY POSSIBLE MANUFACTURING ISSUE RELATED TO THE REPORTED EVENT. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1242834) FOR SIMILAR EVENT (COMPLAINT KEYWORD CATEGORY: FRACTURE : MOUNT, FRACTURE SCREW) AND NO OTHER COMPLAINT WAS IDENTIFIED. POST MARKET TRENDING REVIEW: OCTOBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED DEVICES AND EVENTS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS OCCURRED AND THE REPORTED EVENTS WERE CONFIRMED.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPRESSION POST AND SCREW FRACTURED DURING PLACEMENT. IMPLANT #29 AND HAD TO BE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247262 IMP,TSV,4.1MM,SBM,11.5 DENTAL IMPLANT DZE ZIMMER DENTAL TSV4B11 1242834 00889024019232

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male