BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 13MM

    MDR report key: 14167660 · Received April 21, 2022

    Report

    Report Number
    0002023141-2022-00955
    Event Type
    Injury
    Date Received
    April 21, 2022
    Date of Event
    January 25, 2022
    Report Date
    October 5, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019584
    PMA / PMN Number
    K061410
    Adverse Event
    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). PATIENT WEIGHT NOT PROVIDED. ADDITIONAL 510(K) NUMBERS ARE K011028 AND K013227.

    Additional Manufacturer Narrative · 0

    ONE (1) IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 13MM (TSVH13) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE AND BONE RESIDUE AROUND EXTERNAL THREADS. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. A PRE-EXISTING CONDITION NOTED ON THE PER WAS HIGH BONE DENSITY (TYPE I) PATIENT IS A SMOKER. THE REPORTED DEVICE WAS LOCATED ON TOOTH # 4 (UNIVERSAL) AND WAS USED FOR APPROXIMATELY 10 MONTHS. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. REVIEW OF APPROPRIATE DOCUMENTATION: INSTRUCTIONS FOR USE FOR TAPERED SCREW-VENT® AND TRABECULAR METAL¿ IMPLANTS IFU 4869 REV 9 ¿ 10/19. INFORMATION IDENTIFIED: CONTRAINDICATIONS WARNINGS CHANGES IN PERFORMANCE ADVERSE EFFECTS. DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER: (1232808). 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 WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. STERILIZATION RECORD (OP#110) WAS REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER: (1232808) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ALLERGIC REACTION. POST MARKET TREND REVIEW: JULY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (ALLERGIC REACTION) OR PRODUCT (TSVH13). NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS NON-VERIFIABLE. SECTIONS UPDATED: B4: DATE OF THIS REPORT. G3: DATE INVESTIGATION RESULTS WERE RECEIVED. G6: TYPE OF REPORT AND FOLLOW UP NUMBER. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED. H6: ADVERSE EVENT PROBLEM CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DOCTOR REMOVED THE IMPLANT AFTER THE PATIENT INFORMED HIM THAT HE HAD A TITANIUM ALLERGY.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1920380 IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 13MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVH13 1232808 00889024019584

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention