BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.1MM,DUAL SEL,HA

    MDR report key: 12001062 · Received June 15, 2021

    Report

    Report Number
    0002023141-2021-01536
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 5, 2021
    Report Date
    October 14, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019300
    PMA / PMN Number
    K072589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMP, TSV,4.1MM,DUAL SEL,HA (TSV4H10) WITH MOUNT AND SCREW WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE BUT NO APPARENT MALFUNCTION IDENTIFIED WITH THE THREADS/DRIVE FEATURE. SOME SIGNS OF USE. PRODUCT MATCHED PRINT SPECIFICATION WHERE MEASURED (CALIPER ID: CAL1831 DUE: (B)(6), 2021; INSPECTED ON (B)(6) 2021) FUNCTIONAL TESTING WAS PERFORMED AND THE DEVICES WERE NORMALLY ASSEMBLED. NO DAMAGES TO THREADS IDENTIFIED. PRE-EXISTING CONDITION AS NOTED ON THE PER WAS TYPE III (LOW) BONE DENSITY. THE DEVICE WAS LOCATED ON TOOTH LOCATION #3 (UNIVERSAL) AND THE IMPLANT WAS PLACED AND REMOVED SAME DAY. X-RAY & PICTURE EVALUATION: X-RAY OR PICTURE IMAGE WAS NOT PROVIDED. DHR REVIEW FOR THE LOT (1232710) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW BY LOT NUMBER (1232710) 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 UNCONFIRMED. 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). PATIENT WEIGHT UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO STRIPPED THREADS. WHILE PERFORMING IMPLANT SURGERY, THEY WENT TO PLACE THE IMPLANT AND WERE UNABLE TO USE IT BECAUSE THE THREADS WERE STRIPPED AND IT WOULD NOT STAY IN THE BONE. THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894515 IMP,TSV,4.1MM,DUAL SEL,HA DENTAL IMPLANT DZE ZIMMER DENTAL TSV4H10 1232710 00889024019300

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR