BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15121871 · Received July 28, 2022

    Report

    Report Number
    0002023141-2022-01910
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Date of Event
    July 21, 2022
    Report Date
    January 4, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020092
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). EMAIL UNKNOWN / NOT PROVIDED. K011028, K013227.

    Additional Manufacturer Narrative · 0

    AN IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM (TSVWH10) AND AN UNKNOWN ZIMMER HA WERE NOT RETURNED. SINCE PRODUCTS HAVE NOT BEEN RETURNED, VISUAL/FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED DEVICES LOCATION IS #20 AND LENGTH OF USAGE ARE UNKNOWN. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1232994). 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. DHR REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBERS ASSOCIATED WITH THE REPORTED PRODUCT ARE NOT AVAILABLE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT WITHIN SPECIFICATIONS. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1232994) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. NO COMPLAINT HISTORY REVIEW COULD BE PERFORMED WITHOUT RELEVANT LOTS AND ITEMS INFORMATION FOR UNKNOWN ZIMMER HA. NOV POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICE. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT, G3: DATE RECEIVED BY MANUFACTURER, G6: CHECKED "FOLLOW-UP", H2: CHECKED FOLLOW-UP TYPE, H3: CHANGED "YES" TO "NO", H6: ENTERED EVALUATION CODES, H10: ADDED MANUFACTURER NARRATIVE. H3 OTHER TEXT : DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEALING ABUTMENT ON IMPLANT #20 WAS CROSS THREADED. REQUESTED THREAD TAP TO RETAP THE INTERNAL THREADS OF IMPLANT.

    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
    2286203 IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWH10 1232994 00889024020092

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female