BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM

    MDR report key: 11616570 · Received April 5, 2021

    Report

    Report Number
    0002023141-2021-00859
    Event Type
    Injury
    Date Received
    April 5, 2021
    Date of Event
    March 11, 2021
    Report Date
    July 2, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019522
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE (1) IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM (TSVB13) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE IMPLANT RETURNED WITH HEALING ABUTMENT. NO APPARENT MALFUNCTION IDENTIFIED. BONE DEBRIS AND DRIED BLOOD PRESENT ON IMPLANT EXTERNAL THREADS. PRODUCT MATCHED PRINT SPECIFICATION WHERE MEASURED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. A PRE-EXISTING CONDITION NOTED ON THE PER WAS LOW BONE DENSITY (TYPE III). THE REPORTED DEVICE WAS LOCATED ON TOOTH # 26 (UNIVERSAL) AND WAS USED FOR APPROXIMATELY 1 MONTH AND 18 DAYS. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW FOR THE LOT (1232294) 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. ALL STERILIZATION ACTIVITIES WERE CONDUCTED WITH NO NONCONFORMITIES PER STERILIZATION RECORD. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS WITHIN SPECIFICATIONS COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1232294) FOR SIMILAR EVENT KEYWORD CATEGORY (MEDICAL : PAIN) AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS NON-VERIFIABLE. 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). PMA/510(K): K011028, K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 26 LOST INTEGRATION AND WAS REMOVED DUE TO PAIN. PER INDICATED: PAIN IS THE ONLY THING MARKED ON THE PER. ADDITIONAL APPOINTMENT REQUIRED: YES, TO REPLACE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510170 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB13 1232294 00889024019522

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention