BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SP 4.8MM 10M M OCTAGON

    MDR report key: 6631198 · Received June 9, 2017

    Report

    Report Number
    0001038806-2017-00311
    Event Type
    Malfunction
    Date Received
    June 9, 2017
    Date of Event
    April 18, 2017
    Report Date
    September 27, 2017
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    PK082639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MFR NUMBER 0001038806-2017-00311 WAS SUBMITTED WITH THE INCORRECT ITEM NUMBER, THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY. 510K CONTINUED K011245/K002188.

    Additional Manufacturer Narrative · 1

    DEVICE IS SOLD AS BUNDLE WITH IMPLANT ITEM# SPWB10 LOT# 63218889. ADDITIONAL 510K #K002188. DEVICE HAS NOT BEEN RETURNED TO MANUFACTURE. X-RAYS WERE PROVIDED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    A REPLACEMENT SCREW (URS1) WAS RETURNED. VISUAL INSPECTION OF THE AS RECEIVED PRODUCT IDENTIFIED THAT THE SCREW WAS SLIGHTLY BENT ALONG THE SHAFT. THERE WERE NOTICEABLE SIGNS OF WEAR DUE TO USAGE AROUND THE THREADS AND THE SHAFT. THE HEX CIRCUMFERENCE HAD EVIDENCE OF GOUGING AND THE HEX. THERE WAS PRESENCE OF UNCONFIRMED FOREIGN/BIOLOGICAL MATERIAL AROUND THE THREADS. X-RAY PROVIDED DOES NOT IDENTIFY THE REPORTED FAILURE. REVIEW OF THE DHR AND COMPLAINT REVIEW DID NOT PROVIDE ANY INDICATION OF A MANUFACTURING NONCONFORMITIES/DEVIATION OR MATERIAL DEFICIENCIES THAT WOULD CONTRIBUTE TO THIS EVENT. DOCUMENT TYPE(S) REVIEWED: INFORMATION IDENTIFIED: ¿ INSTRUCTIONS FOR USE FOR ZIMMER DENTAL IMPLANT SYSTEMS (4894I REV. 3 - 07/09) INFORMATION IDENTIFIED: SEATING OF PROSTHETIC COMPONENTS INTERNAL HEX OR OCTAGON COMPONENTS - TO PROPERLY SEAT THESE PROSTHETIC COMPONENTS, PLACE THE ABUTMENT RETAINING SCREW THROUGH THE ABUTMENT AND PLACE THE ASSEMBLY INTO THE INTERNAL BEVEL AT THE CORONAL PORTION OF THE IMPLANT. ROTATE IT UNTIL THE ABUTMENT DROPS INTO PLACE. THE MALE HEX OR OCTAGON SHOULD SEAT FULLY IN THE FEMALE HEX OR OCTAGON OF THE IMPLANT ONCE THE TORQUE WRENCH HAS BEEN USED TO TIGHTEN THE ABUTMENT TO 30NCM. THE COMPLAINT WAS CONFIRMED, AS THE SCREW WAS BENT ALONG THE SHAFT. THERE WERE SIGNS OF WEAR AROUND THE THREADS AND THE HEX. A SINGULAR CAUSE FOR THE EVENT COULD NOT BE IDENTIFIED. UDI # (B)(4).

    Description of Event or Problem · 1

    DR. INDICATED THE FINAL PROSTHESIS WAS CREATED USING THE FIXTURE MOUNT THAT WAS ATTACHED TO IMPLANT (SPWB10) IN TOOTH LOCATION #19. ON (B)(6) 2017 THE PATIENT CAME TO THE DENTAL OFFICE AGAIN DUE TO A LOOSE RESTORATION AND THE DENTIST TRIED TO TIGHTEN THE RETAINING SCREW (URS1) THAT IS ATTACHED TO THE FIXTURE MOUNT INSIDE OF THE IMPLANT AND IT WAS NOT POSSIBLE TO TIGHTEN THE SCREW BECAUSE THE SCREW ROTATE WITH THE FIXTURE MOUNT, THEN THE PROSTHESIS WAS REMOVED AND IT WAS FOUNDED THAT THE SCREW WAS BENT. THE DOCTOR CONFIRMED THAT THE FIXTURE MOUNT AND SCREW WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413300 IMPL TAPERED SP 4.8MM 10M M OCTAGON DENTAL IMPLANT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1