BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,3.7,8,MTX,MG

    MDR report key: 12214349 · Received July 22, 2021

    Report

    Report Number
    0002023141-2021-01895
    Event Type
    Injury
    Date Received
    July 22, 2021
    Date of Event
    July 6, 2021
    Report Date
    December 30, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019966
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMP, TSV,3.7,8, MTX, MG (TSVTB8) WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, VISUAL EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION WAS PERFORM USING APPLICABLE INSTRUCTION FOR USE, RISK FILES AND OTHER AVAILABLE INFORMATION. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE PRODUCT WAS NOT RETURNED. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE DEVICE WAS INTENDED FOR TOOTH # 3. X-RAY IMAGES WERE PROVIDED (FILE: X-RAY). THE DEVICE POSITION DEFERS FROM ONE IMAGE TO ANOTHER CONFIRMING THE REPORTED MIGRATION EVENT. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW FOR THE LOT (1222987) 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. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1222987) FOR SIMILAR EVENTS AND 1 OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED. HOWEVER, THE REPORTED EVENT HAS BEEN CONFIRMED FOLLOWING X-RAY EVALUATION.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 LOST INTEGRATION AND WAS REMOVED. IT MIGRATED CLOSE INTO THE SINUS, BUT DID NOT GO IN. THE IMPLANT WAS REMOVED AND SITE GRAFTED. ADDITIONAL APPOINTMENT REQUIRED: YES, FUTURE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1110792 IMP,TSV,3.7,8,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTB8 1222987 00889024019966

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention