BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 9460271 · Received December 12, 2019

    Report

    Report Number
    0002023141-2019-01285
    Event Type
    Injury
    Date Received
    December 12, 2019
    Date of Event
    June 12, 2019
    Report Date
    February 14, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    AN IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 13MM (TSVH13) WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED EVIDENCE OF LIGHT WEAR FROM USE AND REMOVAL DAMAGE. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT IS NOT REQUIRED DUE TO THE NATURE OF THE MEDICAL EVENT. THE PRODUCT'S DIMENSIONS WERE MEASURED WITH DIGITAL CALIPERS (CAL1334, CALIBRATION DUE 25-SEP-2020) AND WERE FOUND TO BE WITHIN THE SPECIFICATIONS IN THE PRODUCT'S ENGINEERING DRAWING. IN ADDITION, THE IMPLANT WAS IN PLACED AT TOOTH LOCATION # 22 AND WAS IN PLACE FOR 3 MONTHS. PRE-EXISTING CONDITIONS WERE NOTED ON THE PER AND INCLUDE THE PATIENT'S REPORTED DIABETES. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED THAT COULD SERVE AS EVIDENCE OF THE REPORTED EVENT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (LOT # 1220456). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCE, 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. STERILIZATION RECORD (OP#110 SHIPMENT 117-101618A) WAS REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1220456) FOR SIMILAR EVENT 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 (INFECTION) OR FOR THE REPORTED DEVICE (ITEM # TSVH13). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS NON-VERIFIABLE. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT; D4: UNIQUE IDENTIFIER (UDI) NUMBER; D4: EXPIRATION DATE; G4: DATE RECEIVED BY MANUFACTURER; G7: CHECKED "FOLLOW-UP"; H2: CHECKED FOLLOW-UP TYPE; H3: DEVICE EVALUATED BY MANUFACTURER; H6: ENTERED EVALUATION CODES; H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT (TSVH13) WAS REMOVED DUE TO PERIIMPLANTITIS AT TOOTH LOCATION 22.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256819 IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 13MM DENTAL IMPLANT DZE ZIMMER DENTAL 1220456

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention