BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,11.5

    MDR report key: 13029023 · Received December 17, 2021

    Report

    Report Number
    0002023141-2021-03654
    Event Type
    Injury
    Date Received
    December 17, 2021
    Date of Event
    November 13, 2021
    Report Date
    May 31, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019232
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE (1) IMP,TSV,4.1MM,SBM,11.5 (TSV4B11), ONE (1) IMP,TSV,4.1MM,SBM,10 (TSV4B10), TWO (2) IMP,TSV,4.1,11.5,MTX,MG (TSVT4B11) WERE RETURNED FOR INVESTIGATION. ONE (1) IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM (TSVB11) WAS NOT RETURNED. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED NO DAMAGE/MALFUNCTION. 3 IMPLANTS (TSV4B10, TSVT4B11X2) DISENGAGED FROM MOUNTS AS INTENDED, AND ONE TSV4B11- ALSO WITH NO DAMAGE IDENTIFIED OR SIGNS OF MALFUNCTION THAT WOULD CONTRIBUTE TO THE EVENT. THE IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM (TSVB11) WAS NOT RETURNED FOR INVESTIGATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM AND LOT NUMBER ALONG WITH THE APPLICABLE DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), AND RISK FILE. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT "DOES NOT DISENGAGE/RELEASE" FOR THE RETURNED IMPLANTS REVEALED, THE DEVICES (TSV4B10, TSVT4B11X2, TSV4B11) DISENGAGED FROM MOUNTS AS INTENDED. A PRE-EXISTING CONDITION NOTED ON THE PER WAS UNKNOWN BONE DENSITY TYPE. THE REPORTED DEVICES WERE LOCATED ON UNKNOWN TOOTH SITES (UNIVERSAL) AND WERE PLACED AND REMOVED ON THE SAME DATE. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. LOT NUMBERS WERE INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBERS FOR SIMILAR EVENTS AND TWO (2) OTHER COMPLAINTS WERE IDENTIFIED, (CMP-0765779, CMP-0781451). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICES MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT, DOES NOT DISENGAGE/RELEASE, WAS UNCONFIRMED.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. GENDER UNKNOWN / NOT PROVIDED. PATIENT WEIGHT UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TRANSFER MOUNT DID NOT COME OFF AND CLINICIAN DID NOT COMPLETE THE PROCEDURE WITH ANOTHER IMPLANT OR ANOTHER DEVICE. NO SYMPTOMS WAS REPORTED. TOOTH# UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1929724 IMP,TSV,4.1MM,SBM,11.5 DENTAL IMPLANT DZE ZIMMER DENTAL TSV4B11 1237362 00889024019232

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention