MAUDE Adverse Event Report: MIS IMPLANTS TECHNOLOGIES LTD. LANCE EXTERNAL HEX. IMPLANT DIA. 3.75 L 16MM; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	EF5-16375
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 16MM
• 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: 20234334
• Report Number: 3004203816-2022-03831
• Device Sequence Number: 8163395
• Product Code: DZE
• UDI-Device Identifier: 07290108991949
• UDI-Public: 07290108991949
• 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: EF5-16375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 09/17/2024
• 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