BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.1MM,SBM,10

    MDR report key: 9590455 · Received January 15, 2020

    Report

    Report Number
    0002023141-2020-00082
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Report Date
    March 20, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K072589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4) DEVICE PACKAGING FOR ONE IMP,TSV,4.1MM,SBM,10 (TSV4B10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT PACKAGING IDENTIFIED OPENED STERILE PACKAGING, NO IMPLANTS OR COMPONENTS FOR BOTH REPORTED LOTS. ADDITIONALLY, THE RETURNED OUTER BOXES WERE TAPED TOGETHER LEADING TO EXTERNAL DAMAGE ON THE OUTER BOXES. DHR REVIEWS WERE COMPLETED FOR THE SUBJECT LOT NUMBERS (1218325). 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, WERE NOTED AS PART OF THE DHRS. LOTS WERE INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEWS WERE PERFORMED FOR THE REPORTED LOT NUMBERS (1218325 & 1221085) FOR SIMILAR EVENT AND NO OTHER COMPLAINTS WERE IDENTIFIED. JANUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (PACKAGING: INCORRECT COMPONENT QUANTITY), REPORTED DEVICES (TSV4B10 & TSVWB10) OR OBSERVED MALFUNCTION (PACKAGING: DAMAGE). THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PACKAGING MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE FOR BOTH DEVICES AS THE RECEIVED CONDITION OF THE PRODUCTS IS UNKNOWN. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA/HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT D4: EXPIRATION DATE AND UDI G4: DATE RECEIVED BY MANUFACTURER G7: TYPE OF REPORT, FOLLOW-UP NUMBER H2: FOLLOW UP TYPE H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE 'NO' TO 'YES' H4: DEVICE MANUFACTURE DATE H6: EVALUATION CODES H10: ADDITIONAL NARRATIVE

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (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 IMPLANT WAS MISSING FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56870 IMP,TSV,4.1MM,SBM,10 DENTAL IMPLANT DZE ZIMMER DENTAL 1218325

    Patients

    Seq Age Sex Outcome Treatment
    1