BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECT Ø4, ANTI ROTATION FINAL ESTHETIC ABUTMENT, C=6

    MDR report key: 20135432 · Received September 4, 2024

    Report

    Report Number
    3004203816-2024-00004
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    June 21, 2024
    Report Date
    September 5, 2024
    Manufacturer
    MIS IMPLANTS TECHNOLOGIES LTD.
    Product Code
    NHA
    UDI-DI
    07290113990630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE RECEIVED FOR THIS EVENT IS BEING CORRECTED FROM MIS XD DRILL TO CONNECT Ø4, ANTI ROTATION FINAL ESTHETIC ABUTMENT, C=6 CATOLOG # MM-CEI46. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION. CORRECTING PRODUCT CODE FROM NDP TO NHA. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION. ADDING ADDITIONA INFORMATION. ADDING UDI (B)(4). THIS IS A FOLLOW UP REPORT FOR THIS ADDITIONAL INFORMATION. ADDING ADDITIONAL INFORMATION. ADDING LOT # W24001760. THIS IS A FOLLOW UP REPORT FOR THIS ADDITIONAL INFORMATION. THIS IS TO CORRECT AND REMOVE THE CODES THAT WERE INITIALLY REPORTED - REMOVING CODES FOR: HEALTH EFFECT - CLINICAL CODE - 4582. HEALTH EFFECT - IMPACT CODE - 2199. MEDICAL DEVICE PROBLEM CODE - 2976. COMPONENT CODE - TYPE OF INVESTIGATION CODE - 3331. INVESTIGATION FINDINGS CODE - 3211 - 150. INVESTIGATION CONCLUSIONS CODE - 57. THE PHYSICAL INVESTIGATION OF THE RETURNED ITEMS REVEALED THAT NO FRACTURE HAD OCCURRED. THE CORRECT CODES FOR THIS COMPLAINT ARE: HEALTH EFFECT - CLINICAL CODE - 1924. HEALTH EFFECT - IMPACT CODE - 4621 - 4627. MEDICAL DEVICE PROBLEM CODE - 1260. COMPONENT CODE - TYPE OF INVESTIGATION CODE - INVESTIGATION FINDINGS CODE - INVESTIGATION CONCLUSIONS CODE - THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION. CORRECTING ADDITIONAL MANUFACTURER NARRATIVE: REMOVING: WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, IF THIS MALFUNCTION RECURRED, IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. AS RESULTS FROM THE INVESTIGATION, IT IS CONCLUDED THAT STANDARD ENGINEERING TESTS PERFORMANCE, IN HARD BONE REPLICA, LED TO SUCCESSFUL PERFORMANCE OF THE DRILLS. IN ADDITION, THE INITIAL VERIFICATION OF THE DESIGN WAS PERFORMED PROPERLY IN ACCORDANCE WITH INTERNAL PROCEDURES AND GUIDING STANDARDS. HOWEVER, INTERNAL DISCUSSIONS ELEVATE THAT THE DRILLS ARE NOT INTENDED FOR APPLYING LATERAL FORCES OR DRILLING WHILE BENDING THE DRILLS. THIS WAS SUPPORTED BY SIMULATING DRILLING TESTS IN BOVINE RIB BONE WHICH CONTAINS THICKER CORTICAL BONE AND HIGHER BONE STRENGTH THAN HUMAN BONE. FOLLOWING THE GATHERED INFORMATION, IT IS CONCLUDED THAT THE IFU OF THE XD DRILLS SHOULD HAVE INCLUDED AN INDICATION STATING THIS PERFORMANCE LIMITATION. YET THIS WAS NOT CONSIDERED, AS THE COMMON CLINICAL PRACTICE GUIDES TO DRILL IN THE PILOT DRILL AXIS. NEVERTHELESS, FOLLOWING THE REPORTED COMPLAINTS IT IS LEARNED THAT ALL CLINICAL PERFORMANCE SCENARIOS SHOULD BE EVALUATED FOR SAFETY PERFORMANCE. ROOT CAUSE: THE IFU OF THE DRILLS DOES NOT INCLUDE THE PERFORMANCE LIMITATION REFERRED TO, AS THE COMMON CLINICAL PRACTICE GUIDES TO DRILL IN THE PILOT DRILL AXIS CORRECTING TO: SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803.

    Additional Manufacturer Narrative · 0

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, IF THIS MALFUNCTION RECURRED, IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. AS RESULTS FROM THE INVESTIGATION, IT IS CONCLUDED THAT STANDARD ENGINEERING TESTS PERFORMANCE, IN HARD BONE REPLICA, LED TO SUCCESSFUL PERFORMANCE OF THE DRILLS. IN ADDITION, THE INITIAL VERIFICATION OF THE DESIGN WAS PERFORMED PROPERLY IN ACCORDANCE WITH INTERNAL PROCEDURES AND GUIDING STANDARDS. HOWEVER, INTERNAL DISCUSSIONS ELEVATE THAT THE DRILLS ARE NOT INTENDED FOR APPLYING LATERAL FORCES OR DRILLING WHILE BENDING THE DRILLS. THIS WAS SUPPORTED BY SIMULATING DRILLING TESTS IN BOVINE RIB BONE WHICH CONTAINS THICKER CORTICAL BONE AND HIGHER BONE STRENGTH THAN HUMAN BONE. FOLLOWING THE GATHERED INFORMATION, IT IS CONCLUDED THAT THE IFU OF THE XD DRILLS SHOULD HAVE INCLUDED AN INDICATION STATING THIS PERFORMANCE LIMITATION. YET THIS WAS NOT CONSIDERED, AS THE COMMON CLINICAL PRACTICE GUIDES TO DRILL IN THE PILOT DRILL AXIS. NEVERTHELESS, FOLLOWING THE REPORTED COMPLAINTS IT IS LEARNED THAT ALL CLINICAL PERFORMANCE SCENARIOS SHOULD BE EVALUATED FOR SAFETY PERFORMANCE. ROOT CAUSE: THE IFU OF THE DRILLS DOES NOT INCLUDE THE PERFORMANCE LIMITATION REFERRED TO, AS THE COMMON CLINICAL PRACTICE GUIDES TO DRILL IN THE PILOT DRILL AXIS.

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED FROM BRAZIL THAT WHEN THE CONNECT SUPERSTRUCTURE (MM-CEI46 CONNECT Ø4, ANTI ROTATION FINAL ESTHETIC ABUTMENT, C=6) WAS REMOVED, THE SCREW FRACTURED EVEN BEFORE THE TORQUE OF 30 NCM WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108265 CONNECT Ø4, ANTI ROTATION FINAL ESTHETIC ABUTMENT, C=6 ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA MIS IMPLANTS TECHNOLOGIES LTD. W24001760 07290113990630
    711530 CONNECT Ø4, ANTI ROTATION FINAL ESTHETIC ABUTMENT, C=6 ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA MIS IMPLANTS TECHNOLOGIES LTD. W24001760 07290113990630

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other