BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT, MTX®

    MDR report key: 6584099 · Received May 23, 2017

    Report

    Report Number
    0001038806-2017-00259
    Event Type
    Injury
    Date Received
    May 23, 2017
    Date of Event
    November 15, 2016
    Report Date
    August 14, 2017
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    PK061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE (1) TAPERED SCREW VENT IMPLANT WAS RETURNED. A VISUAL INSPECTION OF THE RECEIVED PRODUCT REVEALED MODERATE WEAR AND BONE TISSUE ATTACHMENT ABOUT THE THREADED REGION AND IN THE DRIVE FEATURE. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. ALSO A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS FOR THIS PRODUCT LOT. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: INSTRUCTIONS FOR USE FOR SCREW-VENT® IMPLANTS¿ 9665 REV 0-09/14. WARNINGS: SURGICAL AND RESTORATIVE TECHNIQUES REQUIRED TO PLACE DENTAL IMPLANTS ARE HIGHLY SPECIALIZED AND COMPLEX PROCEDURES. PRACTITIONERS SHOULD ATTEND COURSES OF STUDY TO FAMILIARIZE THEMSELVES WITH IMPLANTOLOGY TECHNIQUES. IMPROPER TECHNIQUE CAN CAUSE BONE LOSS, PATIENT INJURY, PAIN AND IMPLANT FAILURE. ZIMMER DENTAL IMPLANT SYSTEMS ARE INTENDED TO BE USED ONLY WITH ZIMMER DENTAL SPECIALLY DESIGNED BONE DRILLS AND PROSTHETICS. IMPLANTS PLACED AT UNSUITABLE ANGLES RELATIVE TO EXISTING DENTITION OR MULTIPLE IMPLANTS PLACED AT CONVERGENT/DIVERGENT MANNER CAN RESULT IN COMPLEX RESTORATIONS THAT MAY OVERLOAD IMPLANTS, POTENTIALLY LEADING TO IMPLANT FAILURE (INCLUDING FRACTURE). A THOROUGH DIAGNOSTIC WORK-UP AND USE OF X-RAYS AND SURGICAL TEMPLATES ARE RECOMMENDED TO HELP ENSURE PROPER ANGULATION AND AVOIDANCE OF CERTAIN ANATOMICAL FEATURES SUCH AS SINUS MEMBRANES, ADJACENT TEETH AND CRANIOFACIAL NERVES. THE RISK MANAGEMENT FILE FOR THE PRODUCT WAS ALSO REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: RISKS ASSOCIATED WITH THE REPORTED DEVICE ARE OUTLINED IN RISK MANAGEMENT FILE RM-002G3 REVISION 2 ¿TAPERED AND STRAIGHT SCREW VENT IMPLANTS WITH MTX SURFACE¿. THIS FILE DESCRIBES THE MECHANISM OF FAILURE AS PATIENT SPECIFIC ON A CASE BY CASE BASIS, WITH AN OCCURRENCE RATE OF ¿OCCASIONAL¿. PROBABLE CAUSES COULD NOT BE DETERMINED FOR THIS COMPLAINT. NO DEVIATIONS WERE IDENTIFIED THROUGH THE INVESTIGATION PERFORMED THAT MAY HAVE CONTRIBUTED TO THE CONDITION THE PATIENT EXPERIENCE IN THIS EVENT. UDI (B)(4).

    Additional Manufacturer Narrative · 1

    THE PMA K011028/K013227. THE DEVICE WAS REQUESTED BUT HAS NOT BEEN RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    PRODUCT RECEIVED, INVESTIGATION IN PROGRESS.

    Description of Event or Problem · 1

    DR. INDICATED (B)(6) 2016 IMPLANTS WERE PLACED ON TOOTH SITES #16 AND #17 WITH SINUS ELEVATION. AFTER 3 MONTHS, IT WAS OBSERVE THAT IMPLANT AT TOOTH SITE #17 HAD FAILED TO INTEGRATE AND RELOCATED INTO THE SINUS. THE IMPLANT WAS REMOVED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366409 IMPLANT, MTX® DENTAL IMPLANT DZE ZIMMER DENTAL 63219947

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention