MAUDE Adverse Event Report: ADIN DENTAL IMPLANT SYSTEMS LTD TOUAREG¿-S DENTAL IMPLANT

Model Number	ISPS1142
Medical Device Problem Codes	Failure to Osseointegrate (1863); Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	01/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant mobility (failure to osseointegrate, loss of osseointegration), bone loss, and infection are common anticipated complications for all similar dental implants in clinical use.These clinical failures are disclosed in adin's implants instructions for use ifu001 under title "adverse reactions".
Event or Problem Description
Failed dental implant, patient reported pain and mobility.

• Brand Name: TOUAREG¿-S DENTAL IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ADIN DENTAL IMPLANT SYSTEMS LTD; industrial zone alon tavor; pob 1128; afula, 18111 01; IS 1811101
• Manufacturer (Section G): ADIN DENTAL IMPLANT SYSTEMS LTD.; industrial zone alon tavor; pob 1128; afula, 18111 01; IS 1811101
• Manufacturer Contact: ilana lutvak ; industril zone alon tavor; pob 1128; afula, 18111-01 ; IS 1811101
• MDR Report Key: 15930507
• Report Number: 3007518363-2022-00001
• Device Sequence Number: 19920309
• Product Code: DZE
• UDI-Device Identifier: 07290105151872
• UDI-Public: 7290105151872
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 11/17/2022

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 Expiration Date: 12/14/2025
• Device Model Number: ISPS1142
• Device Catalogue Number: ISPS1142
• Device Lot Number: 7557813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2020
• 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: 38 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian