BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,3.7,13,MTX,MG

    MDR report key: 15352579 · Received September 2, 2022

    Report

    Report Number
    0002023141-2022-02325
    Event Type
    Injury
    Date Received
    September 2, 2022
    Date of Event
    August 3, 2022
    Report Date
    January 30, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019942
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0002023141-2022-02326, 0002023141-2022-02327, 0002023141-2022-02328, 0002023141-2022-02329. ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0002023141-2022-02326-1, 0002023141-2022-02327-1, 0002023141-2022-02328-1, 0002023141-2022-02329-1. 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, 4110, 4111 AND 4114. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODES WERE ADDED: 4310 AND 4315. ONE (1) IMP,TSV,3.7,13,MTX,MG (TSVTB13), ONE (1) IMP,TSV,4.1,13,MTX,MG (TSVT4B13), ONE (1) IMP,TSV,4.1,11.5,MTX,MG (TSVT4B11) & TWO (2) IMP,TSV,4.1,8,MTX,MG (TSVT4B8) WERE NOT RETURNED FOR INVESTIGATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM AND LOT NUMBER ALONG WITH THE APPLICABLE DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), AND RISK FILE. BASED ON THE EVALUATION, DEVICE MALFUNCTIONS HAVE NOT OCCURRED. ADDITIONALLY, THERE IS NO EXISTING NONCONFORMANCE / CAPA / HHE/D / IE / PRODUCT HOLD AGAINST THE REPORTED DEVICES THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENTS. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ADVERSE EVENTS OR ACTIONABLE TRENDS FOR THE REPORTED EVENTS OR DEVICES. 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 WITHIN SPECIFICATIONS AND CONFORMING WHEN IT LEFT ZIMMER BIOMET. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBERS (1241236, 1244883, 1246677, 1241507, 1239623). 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. STERILIZATION RECORDS (OP#150/OP#160) WERE REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBERS (1241236, 1244883, 1246677, 1241507, 1239623) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. FUNCTIONAL TESTING COULD NOT BE PERFORMED FOR THE REPORTED EVENTS/FAILURE (ALLERGIC REACTION, INFECTION, BONE LOSS). THE REPORTED EVENTS COULD NOT BE RECREATED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, BASED ON THE INVESTIGATION, RISK REVIEW AND IFU, THE MOST LIKELY CAUSES DETERMINED FROM THE INVESTIGATION ARE IMPROPER PATIENT SELECTION ¿ IMPROPER LOADING (I.E. EXCESSIVE CANTILEVER LOADING) -- COMPROMISED SURGICAL FIELD. NO FURTHER INVESTIGATION OR 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

    IT WAS REPORTED THAT THE IMPLANTS AT UNKNOWN TOOTH SITES (5) WERE REMOVED DUE TO ALLERGIC REACTION, INFECTION & BONE LOSS. PATIENT HAD MAXILLARY FULL ARCH PROCEDURE AND PRESENTED COMPLAINING OF PAIN. TREATED FOR INFECTION AND PAIN BUT DID NOT RESOLVE AND IMPLANTS WERE REMOVED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2367889 IMP,TSV,3.7,13,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTB13 1241236 00889024019942

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention