BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.7,16,MTX,MG

    MDR report key: 12527382 · Received September 24, 2021

    Report

    Report Number
    0002023141-2021-02670
    Event Type
    Injury
    Date Received
    September 24, 2021
    Date of Event
    August 26, 2021
    Report Date
    February 23, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020023
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. 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: INVESTIGATION TYPE CODES WERE ADDED: 3331, 4109, 4110 AND 4111. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 180. H6: INVESTIGATION CONCLUSIONS CODES WERE ADDED: 4307. H10: NARRATIVE/DATA WAS UPDATED. ONE TAPERED SCREW VENT (TSVTWB16) AND TWO HEAL COLLAR 4.5X5.5, 5MM (HC455) WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS INDICATED SIGNIFICANT SIGNS OF SOMEWHAT DAMAGE ON THE INTERNAL DRIVE FEATURE OF IMPLANT MOST LIKELY MULTIPLE ATTEMPTS AND THREADS OF HEALING COLLAR IDENTIFIED DAMAGED AS WELL. BENT WAS NOT IDENTIFIED ON THE RETURNED HEALING COLLARS. FUNCTIONAL TESTING WAS PERFORMED FOR THE RETURNED PRODUCTS AND THE DEVICES COULD NOT SEAT AS INTENDED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBERS 1241292, 2021021336 AND 2020120441. 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 BY LOT NUMBERS (1241292, 2021021336 AND 2020120441) WAS PERFORMED FOR SIMILAR EVENTS USING KEYWORD (DAMAGED THREADS, DOES NOT SEAT AND BENT) AND NO OTHER SIMILAR COMPLAINT WAS IDENTIFIED. DECEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS OR PRODUCT (TSVTWB16 AND HC455). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED FOR DAMAGED THREADS AND DOES NOT SEAT, HOWEVER, REPORTED EVENT FOR BENT WAS UNCONFIRMED AS MALFUNCTION DID NOT OCCUR.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). MEDICAL PRODUCT- HC455, HEAL COLLAR 4.5X5.5, 5MM, LOT# 2021021336. MEDICAL PRODUCT- HC455, HEAL COLLAR 4.5X5.5, 5MM, 2020120441. ADDITIONAL PMA/510(K) NUMBER ¿ K101880. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE IMPLANT WAS PLACED BUT HAD ISSUES WITH TWO (2) HEALING ABUTMENTS THAT DID NOT FIT. THE IMPLANT WAS STRIPPED INSIDE AND CAUSED THE HEALING COLLARS TO BE BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1424135 IMP,TSV,4.7,16,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTWB16 1241292 00889024020023

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention DENTAL ABUTMENT-SEE H10 NARRATIVE| DENTAL ABUTMENT-SEE H10 NARRATIVE| DENTAL ABUTMENT| DENTAL ABUTMENT