BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 13MM

    MDR report key: 15709583 · Received November 1, 2022

    Report

    Report Number
    0002023141-2022-02747
    Event Type
    Injury
    Date Received
    November 1, 2022
    Date of Event
    October 20, 2022
    Report Date
    February 27, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020061
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ONE (1) IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 13MM (TSVWB13) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE IMPLANT HAD BONE DEBRIS ON EXTERNAL THREADS. THERE WAS NO DAMAGE, WEAR, OR SIGNS OF MALFUNCTION THAT WOULD CONTRIBUTE TO THE EVENT. MEASUREMENT¿S MATCH DRAWING, THEY WERE MEASURED BY USING CALIPER (CAL3845 DUE: AUG 30, 2023). NO MALFUNCTION WAS IDENTIFIED DURING ANALYSIS. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. A PRE-EXISTING CONDITION WAS NOT NOTED ON THE PER WAS THE BONE DENSITY TYPE WAS UNKNOWN. THE REPORTED DEVICE WAS LOCATED ON TOOTH # 15 (UNKNOWN DENTAL NOTATION SYSTEM) AND WAS IMPLANT AND EXPLANTED ON THE SAME DAY. X-RAY & PICTURE EVALUATION: THE CUSTOMER DID NOT PROVIDE ANY IMAGES FOR THE REPORTED EVENT. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1252141. 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. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1252141 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. DECEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. THEREFORE, BASED ON THE AVAILABLE INFORMATION AND DIMENSIONAL ANALYSIS, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS NON-VERIFIABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #15 WAS REMOVED DUE TO SINUS PERFORATION. IMPLANT WAS INSTALLED USING SURGICAL GUIDE. PA CONFIRMED THAT THE IMPLANT PERFORATED THROUGH FLOOR OF MAXILLARY SINUS. IMPLANT WAS REMOVED AND REPLACED WITH A SHORTER 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
    437224 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 13MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB13 1252141 00889024020061

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention