BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM

    MDR report key: 11582537 · Received March 29, 2021

    Report

    Report Number
    0002023141-2021-00779
    Event Type
    Injury
    Date Received
    March 29, 2021
    Date of Event
    March 16, 2021
    Report Date
    August 9, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. D10: CONCOMITANT DEVICE- IRT, TOOL IMPLANT REMOVAL SCR TYPE IMP, LOT# 2020071233 G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. H6: TYOE OF INVESTIGATION CODES WERE ADDED: 4109, 4110, 4111 AND 3331. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 3252. H6: INVESTIGATION CONCLUSIONS CODE WAS ADDED: 4307. H10: NARRATIVE/DATA WAS UPDATED. ONE TOOL IMPLANT REMOVAL SCR TYPE IMP (IRT) AND TAPERED SCREW-VENT IMPLANT WERE RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCTS IDENTIFIED THAT THE IMPLANT COLLAR AND IRT TIP WERE FRACTURED. ADDITIONALLY, THE IRT FRAGMENT WAS IDENTIFIED IN THE IMPLANT DRIVE FEATURE AND THERE WAS BONE RESIDUE AROUND THE EXTERNAL THREADS OF THE IMPLANT DUE TO USAGE. PER THE APPLICABLE IFU, UNDER THE SECTION WARNINGS, IT IS STATED THAT ZIMMER DENTAL IMPLANT SYSTEMS ARE INTENDED TO BE USED ONLY WITH ZIMMER DENTAL SPECIALLY DESIGNED BONE DRILLS AND PROSTHETICS. ADDITIONALLY, IF THE IMPLANT IS STILL FIRMLY IN BONE INSTEAD OF BEING LOOSE, THE IRT CAN BREAK. ADDITIONALLY, IT IS STATED THAT IMPROPER TECHNIQUES, SEVERE BRUXISM, CLENCHING, AND OVERLOADING, MAY CAUSE COMPONENT FRACTURE. BASED ON THE EVALUATION, DEVICE MALFUNCTION HAS OCCURRED. HOWEVER, THERE IS NO EXISTING NONCONFORMANCE / CAPA / HHE/D / IE / PRODUCT HOLD AGAINST THE REPORTED DEVICES THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENTS. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS OR DEVICES. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCTS WERE WITHIN SPECIFICATIONS AND CONFORMING WHEN THEY LEFT ZIMMER BIOMET. DHR REVIEW FOR THE LOT (2020071233) 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. HOWEVER, THE DHR COULD NOT BE REVIEWED FOR THE IMPLANT SINCE THE LOT NUMBER WAS UNKNOWN. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (2020071233) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: FRACTURE & FRACTURE: IMPLANT) AND NO OTHER COMPLAINT WAS IDENTIFIED. ADDITIONALLY, COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE TSVB8 DATING BACK TO 12 MONTHS FROM NOW. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED PRODUCT FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORD: FRACTURE & FRACTURE: IMPLANT). FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE DEVICES WERE FRACTURED. THEREFORE, THE REPORTED EVENTS COULD NOT BE RECREATED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, BASED ON THE INVESTIGATION, RISK REVIEW AND IFU, THE MOST LIKELY CAUSES FOR THE REPORTED EVENT ARE APPLICATION OF LOADS THAT EXCEED THE INTENDED DESIGN PARAMETERS - CAUSING TOOL WEAR AND PARAFUNCTIONAL HABITS OF PATIENTS OR INCORRECT PLACEMENT OF IMPLANT. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT IDENTIFIER: (B)(6). WEIGHT UNKNOWN / NOT PROVIDED. LOT NUMBER UNKNOWN / NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBER ¿ K011028/K013227. LAST GIVEN NAME UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHILE REMOVING A FRACTURED IMPLANT, THE IRT TIP BROKE OFF. TOOTH# 30. THEY DID FINISH THE REMOVAL WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478019 IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM DENTAL IMPLANT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention DENTAL DRIVER TOOL-SEE H10 NARRATIVE