BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.7,10,MTX,MG

    MDR report key: 15146886 · Received August 2, 2022

    Report

    Report Number
    0002023141-2022-01937
    Event Type
    Injury
    Date Received
    August 2, 2022
    Date of Event
    April 21, 2022
    Report Date
    September 9, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019997
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. 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.

    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, 4110, 4111 AND 3331. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODE WAS ADDED: 67. H10: NARRATIVE/DATA WAS UPDATED. ONE IMP, TSV,4.7,10, MTX, MG (TSVTWB10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE BUT NO APPARENT SIGNS OF MALFUNCTION. BASED ON THE EVALUATION AND DIMENSIONAL ANALYSIS, DEVICE MALFUNCTION HAS NOT OCCURRED. HOWEVER, THERE IS NO EXISTING NON-CONFORMANCE / CAPA / HHE/D / IE / PRODUCT HOLD AGAINST THE REPORTED DEVICE THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ACTIONABLE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCT WAS WITHIN SPECIFICATIONS AND CONFORMING WHEN IT LEFT ZIMVIE. DHR REVIEW FOR THE LOT (1251868) REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1251868) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: MEDICAL: OTHER (PRESSURE IN SINUS) AND NO OTHER COMPLAINT WAS IDENTIFIED. THE IMPLANT COULD NOT BE FUNCTIONALLY TESTED FOR THE REPORTED FAILURE (PRESSURE IN SINUS) AS IT IS A MEDICAL EVENT. THEREFORE, THE REPORTED EVENT COULD NOT BE RECREATED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE INVESTIGATION, RISK REVIEW AND IFU, THE PROBABLE CAUSES FOR THE REPORTED EVENT ARE IMPROPER TECHNIQUE USED DURING PLACEMENT AND PATIENT FACTORS ¿ POOR BONE DENSITY (TYPE IV). 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 COMPLAINED OF PAIN AND PRESSURE IN THE SINUS AND THE IMPLANT AT TOOTH LOCATION #3 WAS 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
    2080696 IMP,TSV,4.7,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTWB10 1251868 00889024019997

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention