BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 13MM

    MDR report key: 8832883 · Received July 26, 2019

    Report

    Report Number
    0002023141-2019-00471
    Event Type
    Injury
    Date Received
    July 26, 2019
    Report Date
    November 1, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 13MM (TSVWB13) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WEAR AND DEBRIS ABOUT THE IMPLANT THREADS. THE PRODUCT MATCHED PRINT SPECIFICATIONS WHERE MEASURED AGAINST DRAWINGS PD-TSVWB13 REV L AND PD-TSVB13 REV L.THE PATIENT HAS A HISTORY OF SMOKING, WHICH COULD CONTRIBUTE TO THE MEDICAL EVENT. THE REPORTED PRODUCT WAS LOCATED ON TOOTH SITES 7 AND USED FOR AN UNKNOWN PERIOD OF TIME PRIOR TO REMOVAL. THE CUSTOMER HAS RETURNED X-RAYS OF THE DEVICES, HOWEVER SME REVIEW OF THE IMAGES NOTED THAT BONE LOSS COULD NOT BE VERIFIED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1216381. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, 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 (1216381) FOR SIMILAR CAUSE AND 1 OTHER COMPLAINT WAS IDENTIFIED UNDER CMP-0532543, WHICH IS A RELATED COMPLAINT. AUGUST POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (BONE LOSS) OR PRODUCT (TSVWB13). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS NOT OCCURRED AND THE REPORTED EVENT WAS NON-VERIFIABLE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT D4: UNIQUE IDENTIFIER (UDI) NUMBER: (01)00889024020061(17)230531(10)1216381 D4: EXPIRATION DATE G4: DATE RECEIVED BY MANUFACTURER G7: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: DEVICE EVALUATED BY THE MANUFACTURER. H4: MANUFACTURER DATE. H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS AT SITE LOCATION#7. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT . D6: IMPLANT DATE: UNKNOWN. G4: DATE RECEIVED BY MANUFACTURER. G7: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT IMPLANT AT TOOTH # 7 WAS REMOVED DUE TO BONE LOSS. IMPLANT DATE REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    ASSOCIATED WITH # 0002023141-2019-00472.

    Description of Event or Problem · 1

    THE CLINICIAN INDICATED THAT THE IMPLANT AT TOOTH SITE # 7 WAS REMOVED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627509 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 13MM DENTAL IMPLANT DZE ZIMMER DENTAL 1216381

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention