MAUDE Adverse Event Report: MIS IMPLANTS TECHNOLOGIES LTD. LANCE EXTERNAL HEX. IMPLANT DIA. 3.75 L 13MM; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	EF5-13375
Medical Device Problem Code	Osseointegration Problem (3003)
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.Day of surgery/0-4 weeks from surgery.
Additional Manufacturer Narrative
Because a serious injury resulted, this event 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 is being submitted as a part of a retrospective review and remediation effort based on enhancements and harmonization made to the company's complaint handling processes.There is no change to device performance or to the device risk profile.A capa: 2304133 has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.This retrospective review covers the date range of 04/06/2022 - 07/28/2024.

• Brand Name: LANCE EXTERNAL HEX. IMPLANT DIA. 3.75 L 13MM
• Common Device Name: IMPLANT, ENDOSSEOUS, ROOT-FORM
• 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 ; 22 w. philadelphia st.; suite 60w; york, PA 17401
• MDR Report Key: 20648735
• Report Number: 3004203816-2024-06858
• Device Sequence Number: 21038057
• Product Code: DZE
• UDI-Device Identifier: 07290108991956
• UDI-Public: 07290108991956
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K040807
• 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

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: EF5-13375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 11/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown