MAUDE Adverse Event Report: MIS IMPLANTS TECHNOLOGIES LTD. M4 INTERNAL HEX. IMPLANT DIA. 5 L 13MM; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	MF4-13500
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a dental implant loss.
Additional Manufacturer Narrative
Since this event resulted in a serious injury, it is reportable per 21 cfr part 803.The device was not evaluated because the issue is a known inherent risk of the device.We will continue to track and monitor the trend.This mdr report is a late submission.A capa (ncr2405716) has been issued.

• Brand Name: M4 INTERNAL HEX. IMPLANT DIA. 5 L 13MM
• Common Device Name: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): MIS IMPLANTS TECHNOLOGIES LTD.; p.o. box 7; bar lev industrial park 20156 00; IS 2015600
• Manufacturer (Section G): MIS IMPLANTS TECHNOLOGIES LTD.; p.o. box 7; bar lev industrial park 20156 00; IS 2015600
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 21440382
• Report Number: 3004203816-2025-11033
• Device Sequence Number: 4349000
• Product Code: DZE
• UDI-Device Identifier: 07290108991611
• UDI-Public: 07290108991611
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K180282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MF4-13500
• Device Lot Number: W16010759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2024
• Distributor Facility Aware Date: 10/31/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male