BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT,TM, MTX®

    MDR report key: 6566462 · Received May 15, 2017

    Report

    Report Number
    0001038806-2017-00239
    Event Type
    Injury
    Date Received
    May 15, 2017
    Date of Event
    April 10, 2017
    Report Date
    August 14, 2017
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    PK132258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510K DEVICE CODES- K113753, K112160. DEVICE HAS YET TO BE RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR INSPECTION. PHOTOGRAPHS OF A TRABECULAR METAL IMPLANT (TMM4B13) WERE PROVIDED. VISUAL INSPECTION OF THE PHOTOGRAPHS DID NOT IDENTIFY ANY SIGNS OF WEAR OR DAMAGE TO THE IMPLANT. 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: ZIMMER DENTAL: INSTRUCTIONS FOR USE FOR TAPERED SCREW-VENT, ADVENT AND TRABECULAR METAL IMPLANTS (4869 REV 7 ¿ 01/16). 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. OTHER RELATIVE WARNINGS INCLUDE STEROID AND ANTICOAGULANT TREATMENT WHICH MAY AFFECT THE SURGICAL SITE, SURROUNDING TISSUE, OR PATIENT¿S HEALING FUNCTION. EXPOSURE TO LONG-TERM USE OF BISPHOSPHONATE DRUGS ESPECIALLY WITH CHEMOTHERAPY MAY IMPACT IMPLANT SURVIVAL. CAREFUL PATIENT SELECTION INCLUDING CONSULTATION WITH THE PATIENT¿S PHYSICIAN IS STRONGLY RECOMMENDED PRIOR TO IMPLANT TREATMENT. EXCESSIVE MOBILITY, BONE LOSS, OR INFECTION MAY INDICATE THE IMPLANT IS FAILING. ANY IMPLANT WHICH APPEARS TO BE FAILING SHOULD BE TREATED OR REMOVED AS SOON AS POSSIBLE. IF REMOVAL IS NECESSARY, CURETTE ANY SOFT TISSUE FROM THE IMPLANT SITE AND ALLOW SITE TO HEAL AS THOUGH IT WERE AN ATRAUMATIC EXTRACTION. DUE TO THE METAL CONDUCTIVITY, ELECTROSURGERY AROUND THE IMPLANTS AND INTRAORAL ABUTMENT PREPARATIONS WITHOUT IRRIGATION COULD RESULT IN TISSUE DAMAGE, PATIENT INJURY AND IMPLANT FAILURE. TAPERED SCREW-VENT IMPLANT SYSTEM ¿ SURGICAL MANUAL (5161 REV ¿ 05/17). INFORMATION IDENTIFIED: IMPLANT DENTISTRY IS GUIDED BY THE RESTORATIVE ASPECT OF THE PROCEDURE. THEREFORE, IT IS A PREREQUISITE TO EVALUATE THE POSITION OF THE SURROUNDING ANATOMICAL LANDMARKS AND NATURAL TEETH RELATIVE TO THE PROPOSED AREA FOR IMPLANT PLACEMENT. THE RISK MANAGEMENT FILE FOR THE PRODUCT WAS ALSO REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: THE RISK MANAGEMENT FILE FOR TMM4B13 IMPLANT WAS REVIEWED. RM-002Y2 TRABECULAR METAL IMPLANT INCLUDES FOLLOWING PROBABLE CAUSES FOR ISSUES WITH IMPLANT FIT: IMPROPER SURGICAL PRACTICES (I.E. DRILLING TOO LARGE OF A DIAMETER). IMPROPER PATIENT SELECTION CRITERIA. THE COMPLAINT COULD NOT BE VERIFIED, AS THERE WERE NO MANUFACTURING DEVIATIONS IDENTIFIED WITH THE IMPLANT THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE EXACT DETAILS OF THE DEVICE USAGE ARE UNKNOWN. THE CONDITIONS UNDER WHICH THE IMPLANT WAS SUBJECTED IN THE PATIENT¿S MOUTH ARE UNKNOWN. PHOTOGRAPHS PROVIDED DID NOT IDENTIFY ANY SIGNS OF DAMAGE OR MALFUNCTION OF THE IMPLANT. THE RADIOGRAPHS OF THE IMPLANT SITE WERE NOT PROVIDED. THEREFORE, BASED ON THE INFORMATION PROVIDED, A PROBABLE CAUSE ORIGINATING FROM THE ANATOMICAL AND/OR USE CONDITIONS CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE DOCTOR STATED THAT THE IMPLANT (TMM4B13) WAS PLACED ON (B)(6) 2017 AND WAS DETERMINED TO BE TOO LONG FOLLOWING RADIOGRAPH SHOWED IMPLANT ON NERVE. IT WAS CONFIRMED THAT IMPLANT 4.7 X 10 WAS SUCCESSFULLY PLACED THAT SAME DAY WITH NO FURTHER ISSUES. TOOTH LOCATION # 29.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347619 IMPLANT,TM, MTX® DENTAL IMPLANT/FIXTURE MOUNT DZE ZIMMER DENTAL 62661939

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention