BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP, TSV, 4.7, 13, MTXF, MG,HA

    MDR report key: 16250732 · Received January 26, 2023

    Report

    Report Number
    0002023141-2023-00346
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Report Date
    May 18, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024344365
    PMA / PMN Number
    K101880
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER: (B)(4). (B)(6). PMA/510(K) NUMBER: K133339. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ONE (1) IMP, TSV, 4.7, 13, MTXF, MG, HA (TSVTWH13) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED MINOR SIGNS OF USE. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT; VERIFIED THE IMPLANT & MOUNT ENGAGES/DISENGAGES AS INTENDED. NO MALFUNCTION. ADDITIONALLY, THE CUSTOMER INITIALLY REPORTED THAT THE MOUNT AND THE IMPLANT WERE DISENGAGED FROM EACH OTHER. HOWEVER, THAT EVENT COULD NOT BE VERIFIED, AS THE CUSTOMER ALSO REPORTED RE-ATTACHING THE MOUNT TO THE IMPLANT, IN AN ATTEMPT TO PLACE THE IMPLANT DURING SURGERY, THEN LATER ALLEGEDLY, THE CUSTOMER CLAIMED THE IMPLANT FELL WHILE TRANSPORTING THE IMPLANT TO THE PATIENT MOUTH. THE COOB IS NON-VERIFIABLE AS THE CONDITIONS OF THE DEVICE WHEN DELIVERED COULD NOT BE VERIFIED. PRE-EXISTING PATIENT FACTORS, X-RAY, TOOTH LOCATIONS ARE NOT RELEVANT TO THE REPORTED EVENT. THE CUSTOMER DID NOT PROVIDE ANY PICTURES. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1250012). 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 WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1250012) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. FEBRUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (DISENGAGED) OR PRODUCT (TSVTWH13). NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED, AND THE REPORTED EVENT WAS NON-VERIFIABLE WITH THE INFORMATION PROVIDED. ADDITIONALLY, THE CUSTOMER INITIALLY REPORTED THAT THE MOUNT AND THE IMPLANT WERE DISENGAGED FROM EACH OTHER. HOWEVER, THAT EVENT COULD NOT BE VERIFIED, AS THE CUSTOMER ALSO REPORTED RE-ATTACHING THE MOUNT TO THE IMPLANT, IN AN ATTEMPT TO PLACE THE IMPLANT DURING SURGERY, THEN LATER ALLEGEDLY, THE CUSTOMER CLAIMED THE IMPLANT FELL WHILE TRANSPORTING THE IMPLANT TO THE PATIENT MOUTH. THE COOB IS NON-VERIFIABLE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: H3: CHANGED "NO" TO "YES."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS RECEIVED WITH THE MOUNT UNATTACHED. THE CLINICIAN REATTACHED THE MOUNT TO THE IMPLANT AND ATTEMPTED TO PLACE THE IMPLANT. WHILE TRANSPORTING IMPLANT TO THE PATIENT'S MOUTH THE IMPLANT FELL TO THE FLOOR FROM MOUNT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176403 IMP, TSV, 4.7, 13, MTXF, MG,HA DENTAL IMPLANT DZE ZIMMER DENTAL TSVTWH13 1250012 00889024344365

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown