MAUDE Adverse Event Report: MIS IMPLANTS TECHNOLOGIES LTD. MIS XD DRILL; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Model Number MT-SD1350A

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 Description

The distributor of mis in hungary reported that during the implantation process of a seven xd implant 5mm diameter x 13mm length, the xd drill's blades were worn during use and chips were found at patient's oral cavity and tongue.

• Brand Name: MIS XD DRILL
• Type of Device: ACCESSORIES, 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: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 18403696
• MDR Text Key: 331612258
• Report Number: 3004203816-2023-00007
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 07290113997820
• UDI-Public: 07290113997820
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MT-SD1350A
• Device Catalogue Number: MF7-D13500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1