BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 11.5MM LENGTH

    MDR report key: 11130476 · Received January 7, 2021

    Report

    Report Number
    0002023141-2021-00033
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Report Date
    April 15, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024343597
    PMA / PMN Number
    K142082
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4) PACKAGING FOR THE REPORTED EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 11.5MM LENGTH (CM3111) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION IDENTIFIED ONLY THE OUTER BOX WAS RETURNED FOR THE REPORTED CM3111 IMPLANT. ADDITIONALLY, AN OUTER VIAL WAS RETURNED EMPTY WITH THE TAMPER RESISTANT SEAL BROKEN AND LABELED FOR A CM3113 LOT 1232441. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE REPORTED DEVICE & EVENT.NO PER WAS PROVIDED. PRE-EXISTING PATIENT FACTORS AND TOOTH LOCATION ARE NOT RELEVANT TO THE REPORTED EVENT. THE DEVICE WAS REPORTED BEFORE/DURING INITIAL USE. THE CUSTOMER PROVIDED 4 PICTURES (IN THE COMPLAINT) WHICH SHOW THE REPORTED DEVICE PACKAGING IN THE SAME CONDITION AS IT WAS RETURNED. WITH PATIENT TRACEABILITY LABELS FOR CM3113 LOT 1232441 AND CM3111 LOT 1233275, AN OUTER VIAL FOR THE CM3113 AND AN OUTER BOX FOR THE CM3111. THERE WAS NO INNER HOUSING/IMPLANT IN THE PICTURES OR RETURNED. THE CONDITIONS OF THE PRODUCT WHEN THEY FIRST REACHED THE CUSTOMER ARE UNKNOWN. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: IFU 9228 REV 1-11/19; INSTRUCTIONS FOR USE FOR IMPLANTS, ABUTMENTS AND RESTORATIVE COMPONENTS FOR 3.1MMD EZTETIC¿ IMPLANT INFORMATION IDENTIFIED: PRODUCT PACKAGING DHR REVIEW WAS COMPLETED FOR THE REPORTED LOT NUMBER (1233275) AND FOR LOT NUMBER OF THE RETURNED VIAL (1232441). 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 DHRS. LOTS WERE INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. ADDITIONALLY, THE DHR FOR LOT 1233275 WAS FURTHER REVIEWED. FURTHERMORE, A 3I LOT TRACEABILITY REPORT WAS PERFORMED FOR THE LOTS (1233275 AND 1232441) AND THE INVOLVED CUSTOMER (SCHNEIDER FRANCOIS # 25028352) AND EVIDENCE WAS FOUND TO SUPPORT THAT THE CUSTOMER ORDERED BOTH LOTS WHICH SUPPORTS A COMMINGLE OCCURRING OUTSIDE OF ZB CONTROL. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1233275) AND RETURNED VIAL LOT NUMBER (1232441) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. FEBRUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS (PACKAGING: INCORRECT COMPONENT QUANTITY & PACKAGING: INCORRECT OR MISSING LABEL) OR PRODUCT (CM3111). THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PACKAGING MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE AS THE CONDITIONS OF THE PRODUCT WHEN THEY FIRST REACHED THE CUSTOMER ARE UNKNOWN.

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4)

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACKAGING FOR CM3111 IMPLANT WAS EMPTY. DOCTOR REPORTED IN THE INNER BOX THERE WAS NO IMPLANT. THE LOT NUMBER INDICATED ON THE PACKAGING AND THE CAP SAYS 1233275. THE CAP SAYS 3.1 X 1.3. ACCORDING TO THE DOCTOR THERE ALSO WERE 2 SETS OF TRACEABILITY LABELS: CM 3111 LOT 1233275 AND CM3113 LOT 123441 DOCTOR REPORTED THAT ANOTHER IMPLANT WAS PLACED DURING THE SAME SURGERY.

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. PATIENT SEX UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. DATE OF EVENT UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGING FOR CM3111 IMPLANT WAS EMPTY. DOCTOR REPORTED IN THE INNER BOX THERE WAS NO IMPLANT. THE LOT NUMBER INDICATED ON THE PACKAGING AND THE CAP SAYS 1233275. THE CAP SAYS 3.1 X 1.3. ACCORDING TO THE DOCTOR THERE ALSO WERE 2 SETS OF TRACEABILITY LABELS: CM 3111 LOT 1233275 AND CM3113 LOT 123441.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30800 EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 11.5MM LENGTH DENTAL IMPLANT DZE ZIMMER DENTAL CM3111 1233275 00889024343597

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention