BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.7,11.5,MTX,MG

    MDR report key: 14658922 · Received June 10, 2022

    Report

    Report Number
    0002023141-2022-01476
    Event Type
    Injury
    Date Received
    June 10, 2022
    Date of Event
    February 25, 2022
    Report Date
    July 12, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020009
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMP, SV,4.7,11.5, MTX, MG (TSVTWB11), AND COVER SCREW WAS RETURNED FOR INVESTIGATION. THE REPORTED EVENT OCCURRED AT IMPLANT LEVEL. THEREFORE, THIS INVESTIGATION ADDRESSES THE IMPLANTS ONLY. VISUAL EVALUATION OF THE AS RETURNED IMPLANTS IDENTIFIED SIGNS OF USE BUT NO APPARENT SIGNS OF MALFUNCTION/DAMAGE. FUNCTIONAL TESTING COULD NOT BE PERFORMED FOR THE REPORTED EVENTS (NERVE INJURY & PARESTHESIA). MEASUREMENTS WERE TAKEN. THROUGH DIMENSIONAL ANALYSIS THE DEVICES WERE DETERMINED TO BE WITHIN DESIGN SPECIFICATIONS. NO PRE-EXISTING CONDITIONS WERE REPORTED. THE REPORTED DEVICES HAD BEEN PLACED ON TOOTH # 30 FOR APPROXIMATELY 15 DAYS. X-RAY & PICTURE EVALUATION: NO X-RAY/PICTURE PROVIDED. APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED WAS REVIEWED. DHR REVIEW FOR THE 1251362 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. LOTS WERE INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1251362 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION AND DIMENSIONAL ANALYSIS, DEVICE MALFUNCTION DID NOT OCCUR. ADDITIONALLY, THE REPORTED EVENT COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT AND PATIENT ANATOMICAL CONDITIONS WERE UNKNOWN/NONVERIFIABLE.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED, AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED, PATIENT WEIGHT UNKNOWN / NOT PROVIDED , LAST NAME UNKNOWN / NOT PROVIDED. PMA/510: K101880

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED NERVE INJURY, IMPLANT 30 REPLACED DUE TO PARESTHESIA. SHORTER IMPLANT UTILIZED. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: YES, PLACE SHORTER IMPLANTS. ADDITIONAL APPOINTMENT REQUIRED: 2ND STAGE/PROSTHETICS. SYMPTOMS AS A RESULT OF THE EVENT: PARESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2309386 IMP,TSV,4.7,11.5,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTWB11 1251362 00889024020009

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention