BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,MCOL MG,4.7MM,13M

    MDR report key: 17362102 · Received July 20, 2023

    Report

    Report Number
    0002023141-2023-01964
    Event Type
    Injury
    Date Received
    July 20, 2023
    Date of Event
    June 8, 2023
    Report Date
    January 18, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019799
    PMA / PMN Number
    K111889
    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

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). A4: WEIGHT UNKNOWN / NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER ¿ K111889. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. H6: TYPE OF INVESTIGATION CODES WERE ADDED: 4109, 4111 AND 3331. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODE WAS ADDED: 67 AND 4315. H10: NARRATIVE/DATA WAS UPDATED. ZIMVIE RECEIVED THE REPORTED IMPLANT FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE IMPLANT WITH SIGNS OF USE. IMPLANT WAS RETURNED WITH NO DAMAGE THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. MARKINGS LIKELY DUE TO THE REMOVAL PROCESS. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1259399. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1259399 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE MISSING OR CONFUSING INSTRUCTIONS FOR USE, MATERIAL SELECTION. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR. THE REPORTED EVENT WAS NON-VERIFIABLE WITH ALL THE AVAILABLE INFORMATION. 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 PATIENT CAME TO THE OFFICE WITH INFLAMMATION AND PAIN. CBCT SHOWS RL TO THE BUCCAL AND DISTAL OF THE IMPLANT AT TOOTH LOCATION #30. THE IMPLANT WAS REMOVED. IT APPEARS TO BE A METAL ALLERGY. THE SITE WAS DEBRIDED.

    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
    910912 IMP,TSV,MCOL MG,4.7MM,13M DENTAL IMPLANT DZE ZIMMER DENTAL TSVMWB13 1259399 00889024019799

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention