BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,8

    MDR report key: 8685092 · Received June 10, 2019

    Report

    Report Number
    0002023141-2019-00244
    Event Type
    Injury
    Date Received
    June 10, 2019
    Date of Event
    April 18, 2019
    Report Date
    September 5, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN IMP,TSV,4.1MM,SBM,8 (ITEM # TSV4B8) WAS RECEIVED WITH A COVER SCREW THREADED INTO THE DRIVE FEATURE FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNIFICANT DAMAGE (NICKS AND GOUGES) AROUND THE IMPLANT COLLAR, LIKELY DUE TO THE REMOVAL PROCESS. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE EVENT. THE RETURNED PRODUCT DIMENSIONS WERE MEASURED WITH DIGITAL CALIPERS (CAL1334, CALIBRATION DUE (B)(6) 2019) AND WERE FOUND TO BE WITHIN THE SPECIFICATIONS IN THE ENGINEERING DRAWING. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED DEVICE WAS USED FOR APPROXIMATELY 4 DAYS. PICTURES OR X-RAY IMAGES OF THE IMPLANT SITE WERE NOT PROVIDED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1221589). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCE, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (LOT # 1221589) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. JUNE POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS (PERFORATED SINUS AND PAIN) OR DEVICE (TSV4B8). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENTS WERE NON-VERIFIABLE. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT D4: UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4). D4: EXPIRATION DATE. G4: DATE RECEIVED BY MANUFACTURER. G7: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE. THE FOLLOWING SECTIONS HAVE BEEN CORRECTED: G3: REPORT SOURCE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). INITIAL REPORTER EMAIL ADDRESS, FAX NUMBER: NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED A SINUS PERFORATION DURING IMPLANT (TSV4B8) PLACEMENT. IMPLANT WAS REMOVED WITH ENDOSCOPIC TECHNIQUE. TOOTH LOCATION 17.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476246 IMP,TSV,4.1MM,SBM,8 DENTAL IMPLANT DZE ZIMMER DENTAL 1221589

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention