BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM

    MDR report key: 13652492 · Received March 2, 2022

    Report

    Report Number
    0002023141-2022-00546
    Event Type
    Injury
    Date Received
    March 2, 2022
    Date of Event
    January 28, 2022
    Report Date
    April 13, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020085
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL 510(K) NUMBERS ARE K011028 AND K013227.

    Additional Manufacturer Narrative · 0

    ONE TAPERED SCREW-VENT IMPLANT (TSVWB8) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED DRIED BLOOD/BONE RESIDUE AROUND THE EXTERNAL/INTERNAL THREADS DUE TO USAGE BUT NO APPARENT SIGNS OF MALFUNCTION. THE DEVICE COULD NOT BE FUNCTIONALLY TESTED FOR THE REPORTED EVENT (DYSESTHESIA). MEASUREMENTS WERE TAKEN USING A CALIPER (CAL3839, DUE: 02 SEP 2022). FOLLOWING DIMENSIONAL ANALYSIS AND COMPARISON TO DRAWINGS (FILE: DWG), THE DEVICE WAS DETERMINED TO BE WITHIN DESIGN SPECIFICATION. PRE-EXISTING CONDITION NOTED ON THE PER WAS MODERATE BONE DENSITY ¿TYPE II AND IT WAS NOTED THAT THE IMPLANT WAS PLACED IN A PREVIOUSLY OR SIMULTANEOUSLY GRAFTED SITE (ALLOGRAFT). THE REPORTED DEVICE HAD BEEN PLACED ON TOOTH #31 LOCATION FOR APPROXIMATELY 7 DAYS. X-RAY & PICTURE EVALUATION: X-RAY AND PICTURE IMAGES WERE NOT PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE - TAPERED SCREW-VENT AND TRABECULAR METAL IMPLANTS, IFU4869 REV 9-10/19. INFORMATION IDENTIFIED: CONTRAINDICATIONS, WARNINGS & PRECAUTIONS. PER THE APPLICABLE IFU, PATIENT FACTORS SUCH AS POOR BONE QUALITY, POOR PATIENT ORAL HYGIENE, HEAVY TOBACCO USE, UNCONTROLLED SYSTEMATIC DISEASES (DIABETES, ETC.), REDUCED IMMUNITY, ALCOHOLISM, DRUG ADDICTION, AND PSYCHOLOGICAL INSTABILITY MAY CONTRIBUTE TO LACK OF INTEGRATION AND/OR SUBSEQUENT IMPLANT FAILURE. DHR REVIEW: DHR REVIEW FOR THE LOT (1250079) 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. STERILIZATION RECORD REVIEW: ALL STERILIZATION ACTIVITIES WERE CONDUCTED WITH NO NONCONFORMITIES PER STERILIZATION RECORD (OP# 150). ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS WITHIN SPECIFICATIONS COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT (1250079) FOR SIMILAR EVENTS AND NO OTHER SIMILAR COMPLAINTS WERE IDENTIFIED. COMPLAINT CATEGORY KEYWORD(S): MEDICAL. POST MARKET TRENDING REVIEW: FEBRUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION AND DIMENSIONAL ANALYSIS, DEVICE MALFUNCTION DID NOT OCCUR. HOWEVER, THE REPORTED EVENT COULD NOT BE VERIFIED SINCE PATIENT ANATOMICAL/PHYSIOLOGICAL CONDITIONS WERE UNKNOWN/NONVERIFIABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED DYSESTHESIA. RATHER THAN WAIT, THE IMPLANT WAS REMOVED. PT WAS SENT HOME TO HEAL. A SUBSEQUENT FOLLOW-UP REVEALED SYMPTOMS IMPROVING.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267280 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB8 1250079 00889024020085

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention