BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,MCOL MG,3.7MM,16M

    MDR report key: 13042079 · Received December 20, 2021

    Report

    Report Number
    0002023141-2021-03675
    Event Type
    Injury
    Date Received
    December 20, 2021
    Date of Event
    November 11, 2021
    Report Date
    April 28, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019751
    PMA / PMN Number
    K111889
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE IMP, TSV, MCOL MG,3.7MM,16M (TSVMB16) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE BUT NO APPARENT SIGNS OF MALFUNCTION. FUNCTIONAL TESTING COULD NOT BE PERFORMED FOR THE REPORTED EVENT (ALLERGIC REACTION). MEASUREMENTS WERE TAKEN USING CAL3845. FOLLOWING DIMENSIONAL ANALYSIS AND COMPARISON TO DRAWINGS, THE DEVICE WAS DETERMINED TO BE WITHIN DESIGN SPECIFICATION. DEVICE HISTORY RECORD (DHR) REVIEW FOR THE LOT (1233788) 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. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1233788) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: MEDICAL: ALLERGIC REACTION) AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR. THE REPORTED EVENT COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT WERE NONVERIFIABLE.

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. EMAIL ADDRESS UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED ALLERGIC REACTION TO TITANIUM AND WAS REMOVED. DISCOMFORT AND HEADACHE WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1945722 IMP,TSV,MCOL MG,3.7MM,16M DENTAL IMPLANT DZE ZIMMER DENTAL TSVMB16 1233788 00889024019751

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention