BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 11097807 · Received December 30, 2020

    Report

    Report Number
    0002023141-2020-02435
    Event Type
    Injury
    Date Received
    December 30, 2020
    Date of Event
    November 9, 2020
    Report Date
    April 16, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020085
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY CORRECTED DATA AND ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. H6: COMPONENT CODE WAS ADDED: 4755. H6: INVESTIGATION TYPE CODES WERE ADDED: 3331, 4109 AND 4111. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODES WERE ADDED: 67 AND 4310. H10: NARRATIVE/DATA WAS UPDATED. THE REPORTED EVENT IS NON-VERIFIABLE WITH THE INFORMATION PROVIDED AND FOLLOWING INSPECTION OF THE RETURNED DEVICE. BASED ON THE EVALUATION, THE DEVICE MALFUNCTION HAS NOT OCCURRED. THERE IS NO EXISTING NONCONFORMANCE/CAPA/HHE/D/IE/PRODUCT HOLDS AGAINST THE REPORTED PRODUCT THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCT WAS LIKELY WITHIN SPECIFICATION AND LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1233034. 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 WERE 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 (1233034) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. THE REPORTED EVENT COULD NOT BE RECREATED DUE TO THE NATURE OF THE DENTAL DEVICE AND EVENT (MEDICAL CONDITION) AND THE COMPLAINT IS NOT RELATED TO THE FUNCTIONAL PERFORMANCE OF THE PRODUCT. AS PER THE RMF RM-002G3 REV 2, THE POTENTIAL CAUSE FOR THE REPORTED EVENT IS CUSTOMER ERROR IN CASE PLANNING. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. NO IMMEDIATE CAPA/HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO NUMBNESS ON ONE SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562554 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB8 1233034 00889024020085

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention