BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,3.7,8,MTX,MG

    MDR report key: 12488688 · Received September 17, 2021

    Report

    Report Number
    0002023141-2021-02591
    Event Type
    Injury
    Date Received
    September 17, 2021
    Date of Event
    February 18, 2021
    Report Date
    November 5, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019966
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMP, TSV,3.7,8, MTX, MG (TSVTB8) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE (BONE RESIDUE AROUND THE THREADS AND VENT). THE COMPLAINT REPORTED BUCCAL MIGRATION, PARL (PERIAPICAL RADIOLUCENCY) AND BONE LOSS. THE REPORTED EVENTS HAVE BEEN ADDRESSED IN THIS INVESTIGATION. ADDITIONALLY, SIMILAR COMPLAINTS FOR BONE LOSS RELATED PROBLEMS HAVE BEEN PREVIOUSLY INVESTIGATED. THE IMPLANT COULD NOT BE FUNCTIONALLY TESTED FOR THE REPORTED EVENTS (BUCCAL MIGRATION + PARL + BONE LOSS) AS THEY ARE MEDICAL CONDITIONS. MEASUREMENTS WERE TAKEN, THE DEVICE WAS DETERMINED TO BE WITHIN DESIGN SPECIFICATIONS WHEN IT LEFT ZIMMER BIOMET. PRE-EXISTING PATIENT CONDITIONS NOTED ON THE PER WERE RHEUMATOID ARTHRITIS, METHOTREXATE + ENBREL USE, FORMER SMOKER & MODERATE BONE DENSITY ¿ TYPE II. THE REPORTED DEVICE HAD BEEN PLACED ON TOOTH # 26 (UNIVERSAL) FOR APPROXIMATELY 2 YEARS. X-RAY & PICTURE EVALUATION: X-RAY IMAGES WERE PROVIDED (FILE: XRAY). FOLLOWING REVIEW BY SME, BONE LOSS WAS CONFIRMED. HOWEVER, MIGRATION COULD NOT BE CONFIRMED SINCE THE X-RAY WAS TAKEN AT DIFFERENT ANGULATION AND IS TWO DIMENSIONAL. DHR REVIEW FOR THE LOT (1222987) 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. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1222987) FOR SIMILAR EVENTS AND 1 OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION AND DIMENSIONAL ANALYSIS, DEVICE MALFUNCTION DID NOT OCCUR. THE REPORTED BONE LOSS WAS CONFIRMED BUT THE REPORTED EVENTS (MIGRATION + PARL) COULD NOT BE CONFIRMED/VERIFIED THROUGH THE AVAILABLE INFORMATION. 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). PATIENT WEIGHT UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 26 FAILED TO INTEGRATE DUE TO SIGNIFICANT BONE LOSS AT THE IMPLANT SITE AND WAS REMOVED. PATIENT RETURNED TO THE OFFICE FOR TORQUE TEST AND #26 PA FILM REVEALED BUCCAL MIGRATION AND PARL. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386728 IMP,TSV,3.7,8,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTB8 1222987 00889024019966

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention