MAUDE Adverse Event Report: MIS IMPLANTS TECHNOLOGIES LTD. M4 INTERNAL HEX. IMPLANT DIA. 6 L 6MM; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	MF4-06600
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.
Additional Manufacturer Narrative
The date received by manufacturer (g3) was incorrect in the initial report.This report contains the correct date in field g3.

• Brand Name: M4 INTERNAL HEX. IMPLANT DIA. 6 L 6MM
• 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: 21300647
• Report Number: 3004203816-2025-05964
• Device Sequence Number: 8151258
• Product Code: DZE
• UDI-Device Identifier: 07290108991550
• UDI-Public: 07290108991550
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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: MF4-06600
• Device Lot Number: W19005291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/03/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 08/15/2025
• 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: 56 YR
• Patient Sex: Female