BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.1MM,SBM,13

    MDR report key: 7007566 · Received November 7, 2017

    Report

    Report Number
    0001038806-2017-00772
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    October 11, 2017
    Report Date
    February 5, 2018
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    PK072589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE TAPERED SCREW-VENT IMPLANT WITH TRANSFER MOUNT AND PRODUCT LABEL WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE AS RECEIVED PRODUCTS DID NOT IDENTIFY ANY SIGNS OF WEAR OR DAMAGE. DIMENSIONAL ANALYSIS OF THE AS RECEIVED IMPLANT IDENTIFIED THAT THE IMPLANT LENGTH WAS 0.4530 IN. (11.5 MM) AND THE DIAMETER WAS 0.1460 IN. (3.7 MM). THEREFORE, IT WAS CONFIRMED THAT THE SUBJECT IMPLANT IS NOT A TSV4B13. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS AGAINST THIS LOT NUMBER. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: INSTRUCTIONS FOR USE FOR TAPERED SCREW-VENT, ADVENT AND TRABECULAR METAL IMPLANTS (4869 REV 7 ¿ 01/16). STERILITY: ALL IMPLANTS HAVE BEEN GAMMA RADIATION STERILIZED AND ARE FOR SINGLE USE ONLY. DO NOT RESTERILIZE IMPLANTS. ZIMMER DENTAL PROSTHETIC AND ANCILLARY COMPONENTS ARE SOLD STERILE OR NON-STERILE. REFER TO THE SPECIFIC PACKAGING FOR VERIFICATION OF STERILITY. STERILIZE NON-STERILE PRODUCT PRIOR TO USE IN PATIENTS. SOME ZIMMER DENTAL PRODUCTS THAT ARE SOLD STERILE ARE FOR SINGLE USE ONLY; REFER TO SPECIFIC PACKAGING FOR SINGLE USE ONLY DESIGNATION. SHELF LIFE THE PRODUCT EXPIRATION DATE IS INDICATED BY THE HOURGLASS SYMBOL ON THE PRODUCT LABEL, FOLLOWED BY THE YEAR, MONTH, AND SOMETIMES DAY OF EXPIRATION. CAUTION: DO NOT USE STERILE DEVICES IF THE PACKAGING PROVIDING THE STERILE BARRIER, INCLUDING THE OUTER CAP, VIAL, TYVEK®** LID, OR TRAY HAS BEEN DAMAGED OR COMPROMISED IN ANY MANNER (I.E. CRACKED, CRUSHED, TORN OR PEELED AWAY). PRODUCT PACKAGING: ALL IMPLANTS HAVE BEEN CLEANED, PACKAGED IN DOUBLE VIALS WITHIN AN ENVIRONMENTALLY CONTROLLED ROOM, AND STERILIZED FOR CONVENIENCE AND IMMEDIATE USE. THE IMPLANTS ARE SUSPENDED ON A CARRIER FOR TRANSFER TO THE PREPARED SURGICAL SITE WITHOUT RISK OF CONTACT CONTAMINATION. BOTH THE IMPLANT AND THE INNER VIAL PACKAGING ARE STERILE. THE LABEL ON THE OUTER VIAL PACKAGING FOR EACH IMPLANT CONTAINS A LOT NUMBER THAT SHOULD BE RECORDED IN THE PATIENT¿S FILE TO ENSURE COMPLETE TRACEABILITY OF THE PRODUCT. A PATIENT CHART LABEL PROVIDED CONTAINING THE LOT NUMBER CAN ALSO BE PLACED IN THE PATIENT FILE FOR TRACEABILITY. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NONCONFORMANCES WHICH COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT WERE DOCUMENTED IN THE DHR. LOT WAS INSPECTED AND ACCEPTED BY QA. THE COMPLAINT COULD NOT BE VERIFIED, AS THE PRODUCT WAS RETURNED WITHOUT THE ORIGINAL PACKAGING. THEREFORE, THE EXACT DETAILS AND CONDITION OF THE PACKAGING AND THE PRODUCT AS RECEIVED BY THE CUSTOMER ARE UNKNOWN. THERE WERE NO MANUFACTURING DEVIATIONS IDENTIFIED WITH THE IMPLANT LOT THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. A SINGULAR CAUSE CANNOT BE DETERMINED. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING IMPLANT SURGERY WHEN DENTIST OPENED THE TSV4B13 BLISTER, THE IMPLANT INSIDE WAS TSVT. DOCTOR COULD COMPLETE THE PROCEDURE WITH ANOTHER IMPLANT.

    Additional Manufacturer Narrative · 1

    (B)(4). AGE WAS NOT PROVIDED. PATIENT WEIGHT WAS NOT PROVIDED. DEVICE HAS NOT BEEN RETURNED TO MANUFACTURE. PRODUCT NO RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT SURGERY WHEN DENTIST OPENED THE TSV4B13 BLISTER, THE IMPLANT INSIDE WAS TSVT11. DOCTOR COULD COMPLETE THE PROCEDURE WITH ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784899 IMP,TSV,4.1MM,SBM,13 DENTAL IMPLANT DZE ZIMMER DENTAL 63577401

    Patients

    Seq Age Sex Outcome Treatment
    1