MAUDE Adverse Event Report: ADIN DENTAL IMPLANT SYSTEMS LTD TOUAREG CLOSEFIT¿ WP DENTAL IMPLANT 4.3D 11.5L

Model Number	ISPX1143
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Osseointegration (2646)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturers trend analysis show that implant failure is a low-rate adverse event, which is common for endosseous dental implants in clinical use.
Event or Problem Description
Dental implant failure.

• Brand Name: TOUAREG CLOSEFIT¿ WP DENTAL IMPLANT 4.3D 11.5L
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ADIN DENTAL IMPLANT SYSTEMS LTD; industrial zone alon tavor; pob 1128; afula
• Manufacturer (Section G): ADIN DENTAL IMPLANT SYSTEMS LTD; industrial zone alon tavor; pob 1128; afula 18110 1; IS 181101
• Manufacturer Contact: ilana lutvak ; industrial zone alon tavor; pob 1128; afula 18110-1 ; IS 181101
• MDR Report Key: 20234511
• Report Number: 3007518363-2024-41440
• Device Sequence Number: 15464445
• Product Code: DZE
• UDI-Device Identifier: 07290105152275
• UDI-Public: 7290105152275
• Combination Product (Y/N): N
• PMA/510(K) Number: K112585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/31/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ISPX1143
• Device Catalogue Number: ISPX1143
• Device Lot Number: 7758704
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female