BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,3.7,10,MTX,MG

    MDR report key: 11844199 · Received May 18, 2021

    Report

    Report Number
    0002023141-2021-01323
    Event Type
    Injury
    Date Received
    May 18, 2021
    Date of Event
    April 17, 2021
    Report Date
    September 16, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019928
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE TAPERED SCREW VENT (TSVTB10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USAGE AND WHAT APPEARS TO BE DRIED BLOOD INSIDE THE IMPLANT DRIVE FEATURE AND BONE DEBRIS ON THE SCREW VENT. PRODUCT WAS MEASURED AND MATCHED TO THE DHR PRINT DESCRIPTION. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. A PRE-EXISTING CONDITION NOTED ON THE PER WAS NONE. THE REPORTED DEVICE WAS LOCATED ON TOOTH #4 (UNIVERSAL) AND WAS USED FOR APPROXIMATELY 2 DAYS. X-RAY OR PICTURE IMAGE WAS NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW FOR THE LOT NUMBER (1242044) 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 ZIMMER BIOMET. STERILIZATION RECORDS ((B)(4)) WERE REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW BY LOT NUMBER (1242044) WAS PERFORMED FOR SIMILAR EVENTS AND NO OTHER SIMILAR COMPLAINT WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS NON-VERIFIABLE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT G3: DATE RECEIVED BY MANUFACTURER G6: CHECKED "FOLLOW-UP" H2: CHECKED FOLLOW-UP TYPE H3: CHANGED "NO" TO "YES" H6: ENTERED EVALUATION CODES H10: ADDED MANUFACTURER NARRATIVE

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT PLACED (B)(6) 2021. PATIENT CALLED IN EXTREME PAIN THE NEXT DAY AND REQUESTED IMPLANT REMOVAL. IMPLANT #14 WAS REMOVED. PT. NOT RETURNING FOR REPLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737573 IMP,TSV,3.7,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTB10 1242044 00889024019928

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention