BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP, TSV, 4.7,10,MTX,MC,MG,HA

    MDR report key: 14141307 · Received April 19, 2022

    Report

    Report Number
    0002023141-2022-00934
    Event Type
    Malfunction
    Date Received
    April 19, 2022
    Date of Event
    March 11, 2022
    Report Date
    October 6, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024344143
    PMA / PMN Number
    K101880
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT WEIGHT UNKNOWN / NOT PROVIDED. PMA/510: K133339.

    Additional Manufacturer Narrative · 0

    IMP, TSV, 4.7,10,MTX,MC,MG,HA (TSVMWH10) WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED BOTH IMPLANTS WITH SIGNS OF USE. THE COOB COULD NOT BE VERIFIED SINCE, THE DEVICE WAS USED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT; VERIFIED THE IMPLANT WAS UNABLE TO DISENGAGE/RELEASE FROM THE MOUNT. A PRE-EXISTING CONDITION NOTED ON THE PER WAS HIGH BONE DENSITY (TYPE I). THE REPORTED DEVICE WAS LOCATED ON TOOTH # 29 (UNIVERSAL) AND WERE USED, PLACED AND REMOVED ON THE SAME DAY. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1241578). 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, WERE NOTED AS PART OF THE DHR. LOT NUMBERS WERE INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1241578) FOR SIMILAR EVENTS AND ONE (1) OTHER COMPLAINT WAS IDENTIFIED (B)(4). AUG POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT. NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. BASED ON THE AVAILABLE INFORMATION, DEVICES MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED. THE COOB COULD NOT BE VERIFIED SINCE, THE DEVICE WAS USED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D9: DEVICE AVAILABILITY. G3: DATE RECEIVED BY MANUFACTURER. G6: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: CHANGED "NO" TO "YES". H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DR. INDICATED MALFUNCTION. THE IMPLANT BODY CANNOT BE REMOVED FROM THE FIXTURE MOUNT. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED. TOOTH SITE # 29.

    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
    2640376 IMP, TSV, 4.7,10,MTX,MC,MG,HA DENTAL IMPLANT DZE ZIMMER DENTAL TSVMWH10 1241578 00889024344143

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male