BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,6.0,10,MTX,MG

    MDR report key: 12591146 · Received October 7, 2021

    Report

    Report Number
    0002023141-2021-02785
    Event Type
    Injury
    Date Received
    October 7, 2021
    Date of Event
    March 30, 2021
    Report Date
    February 28, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019874
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: H6: INVESTIGATION TYPE CODES WERE ADDED: 3331, 4109 AND 4111. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODES WERE ADDED: 67. AN IMP,TSV,6.0,10,MTX,MG (TSVT6B10) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED SLIGHT BONE ON THREADS. NO FRACTURE IDENTIFIED. THE REPORTED EVENT IS UNCONFIRMED.   ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCT WAS LIKELY WITHIN SPECIFICATIONS AND LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET.   DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1222394). 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.   COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1222394) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED.   THE REPORTED EVENT COULD NOT BE RECREATED DUE TO THE NATURE OF THE DENTAL DEVICE AND EVENT AND THE COMPLAINT IS RELATED TO THE FUNCTIONAL PERFORMANCE OF THE DEVICE.   A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, THE PROBABLE CAUSES ARE NOT APPLICABLE TO THE REPORTED EVENT SINCE THE DEVICE MALFUNCTION DID NOT OCCUR AND THE EVENT IS UNCONFIRMED THROUGH VISUAL AND PHYSICAL INSPECTION.   NO FURTHER INVESTIGATION AND NO IMMEDIATE CAPA/HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL PMA/510(K) NUMBER ¿ K101880. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #15 FRACTURED AND WAS REMOVED. PATIENT HAD A TRAMPOLINE ACCIDENT AND HIT THEIR JAW TO THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487526 IMP,TSV,6.0,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVT6B10 1222394 00889024019874

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention