MAUDE Adverse Event Report: MIS IMPLANTS TECHNOLOGIES LTD. CONNECT Ø4, ANTI ROTATION FINAL ESTHETIC ABUTMENT, C=6; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	MM-CEI46
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: CONNECT Ø4, ANTI ROTATION FINAL ESTHETIC ABUTMENT, C=6
• Common Device Name: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): MIS IMPLANTS TECHNOLOGIES LTD.; p. o. box 7; bar lev industrial park; ha zafon, 20156 00; IS 2015600
• Manufacturer (Section G): MIS IMPLANTS TECHNOLOGIES LTD.; p. o. box 7; bar lev industrial park; ha zafon, 20156 00; IS 2015600
• Manufacturer Contact: dan eagar ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 20135432
• Report Number: 3004203816-2024-00004
• Device Sequence Number: 3226831
• Product Code: NHA
• UDI-Device Identifier: 07290113990630
• UDI-Public: 07290113990630
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MM-CEI46
• Device Lot Number: W24001760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown