BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,11.5

    MDR report key: 13684156 · Received March 7, 2022

    Report

    Report Number
    0002023141-2022-00591
    Event Type
    Injury
    Date Received
    March 7, 2022
    Date of Event
    January 24, 2022
    Report Date
    June 27, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019232
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. TWO TAPERED SCREW-VENT IMPLANTS (TSV4B11 & TSVB13) WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE (BONE RESIDUE) BUT NO APPARENT SIGNS OF MALFUNCTION. THE DEVICES COULD NOT BE FUNCTIONALLY TESTED FOR THE REPORTED FAILURE (PAIN ¿ DYSESTHESIA AND NEURALGIC PAIN). HOWEVER, MEASUREMENTS WERE TAKEN USING A CALIPER. FOLLOWING DIMENSIONAL ANALYSIS AND COMPARISON TO DRAWINGS, THE DEVICES WERE DETERMINED TO BE WITHIN DESIGN SPECIFICATION. DEVICE HISTORY RECORD (DHR) REVIEW FOR THE LOTS (1232329 & 1218775) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMVIE. LOTS WERE INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. ALL STERILIZATION ACTIVITIES WERE CONDUCTED WITH NO NONCONFORMITIES PER STERILIZATION RECORD. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS WITHIN SPECIFICATIONS. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBERS (1232329 & 1218775) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: PAIN, DYSESTHESIA) AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR. HOWEVER, THE REPORTED EVENT COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT WERE NONVERIFIABLE.

    Description of Event or Problem · 0

    DOCTOR REPORTED DYSESTHESIA AND NEURALGIC PAIN. PROCEDURE WAS COMPLETED USING OTHER IMPLANTS.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1784021 IMP,TSV,4.1MM,SBM,11.5 DENTAL IMPLANT DZE ZIMMER DENTAL TSV4B11 1232329 00889024019232

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention