BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM

    MDR report key: 14320498 · Received May 7, 2022

    Report

    Report Number
    0002023141-2022-01120
    Event Type
    Injury
    Date Received
    May 7, 2022
    Date of Event
    March 10, 2022
    Report Date
    August 18, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019515
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT WEIGHT UNKNOWN / NOT PROVIDED. PMA/510K: K013227.

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM (TSVB11) WAS REPORTED BUT NOT RETURNED FOR INVESTIGATION. THEREFORE, VISUAL EVALUATION COULD NOT BE PERFORMED. TWO ASSOCIATED IMPLANTS WERE RETURNED WITH NO ALLEGATIONS AGAINST THEM. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER BUT NO INFORMATION COULD BE OBTAINED. THEREFORE, THIS INVESTIGATION ADDRESSED ONLY THE REPORTED IMPLANT (TSVB11) USING APPLICABLE INSTRUCTIONS FOR USE (IFU), RISK FILES AND OTHER AVAILABLE INFORMATION. FUNCTIONAL TESTING COULD NOT BE PERFORMED FOR THE REPORTED FAILURE (NERVE INJURY). PRE-EXISTING CONDITIONS NOTED IN THE PER WERE INADEQUATE ORAL HYGIENE & LOW BONE DENSITY ¿ TYPE III. THE REPORTED DEVICE WAS INTENDED FOR TOOTH # 21. X-RAY & PICTURE EVALUATION: X-RAY AND PICTURE IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW FOR THE LOT (1240772) 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 (1240772) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED. ADDITIONALLY, THE REPORTED EVENT COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT AND PATIENT ANATOMICAL CONDITIONS WERE NONVERIFIABLE AND UNKNOWN. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G6: CHECKED "FOLLOW-UP". H3: CHANGED YES" TO "NO". H10: ADDED MANUFACTURER NARRATIVE H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM (TSVB11) AND MOUNT WERE RETURNED FOR INVESTIGATION. THE REPORTED EVENT OCCURRED AT IMPLANT LEVEL AND THERE WERE NO ALLEGATIONS AGAINST THE MOUNT. THEREFORE, THE INVESTIGATION ADDRESSED ONLY THE IMPLANT AND THE RELATED EVENT. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE BUT NO APPARENT SIGNS OF MALFUNCTION. TWO ASSOCIATED ITEMS (IMPLANTS) WERE ALSO RETURNED AND DOCUMENTED IN THE COMPLAINT (SEE DL(B)(4)). THERE WERE NO ALLEGATIONS AGAINST THEM. FUNCTIONAL TESTING COULD NOT BE PERFORMED FOR THE REPORTED FAILURE (MEDICAL: OTHER - NERVE INJURY). MEASUREMENTS WERE TAKEN, DIMENSIONAL ANALYSIS HAS FOUND THE DEVICE TO BE WITHIN PRINT SPECIFICATIONS. PRE-EXISTING CONDITIONS NOTED IN THE PER WERE INADEQUATE ORAL HYGIENE & LOW BONE DENSITY ¿ TYPE III. THE REPORTED DEVICE WAS INTENDED FOR TOOTH # 21. X-RAY AND PICTURE IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW FOR THE LOT (1240772) 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 (1240772) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS NOT OCCURRED. ADDITIONALLY, THE REPORTED EVENT COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT AND PATIENT ANATOMICAL CONDITIONS WERE NONVERIFIABLE AND UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DR. INDICATED NERVE INJURY. THE PATIENT CAME TO THE CLINIC DUE TO THE MISSING TOOTH OF LEFT UPPER ANTERIOR ON (B)(6) 2022 AND REQUIRED FOR IMPLANTATION. THE ZIMMER TSV IMPLANT OF 3.7-11.5 WAS IMPLANTED. THE PATIENT FELT SWELLING PAIN DURING THE SURGERY. THE CBCT SHOWED THE COMPRESSION OF THE NASOPALATINE NERVE. THE IMPLANT WAS REMOVED. CHANGE TO ZIMMER TSV IMPLANT OF 3.7-10 AND RE-IMPLANT. TOOTH SITE # 21.

    Description of Event or Problem · 0

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

    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
    1375549 IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM DENTAL INPLANT DZE ZIMMER DENTAL TSVB11 1240772 00889024019515

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Required Intervention