MAUDE Adverse Event Report: CARTIHEAL LTD. AGILI-C

Model Number	AGILI-C 7.5MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject (b)(6), as part of a clinical study was implanted with 1 agili-c implant in the lateral femoral condyle on (b)(6) 2018.On (b)(6) 2023, the subject underwent total knee replacement of the left knee (index knee) due to continued antero-medial knee pain which did not respond to conservative treatment, radio frequency ablation or ha injections.The event was assessed as "unlikely related (to study device and/or tool-set or to study procedure)" by the treating physician (investigator).

• Brand Name: AGILI-C
• Common Device Name: AGILI-C
• Manufacturer (Section D): CARTIHEAL LTD.; 17 atir yeda; kfar saba, 44643 13; IS 4464313
• Manufacturer (Section G): CARTIHEAL; 17 atir yeda; kfar saba, 44643 13; IS 4464313
• Manufacturer Contact: adam waksman ; 3 reuten dr.; closter, NJ 07624
• MDR Report Key: 18456295
• Report Number: 3013881076-2024-00001
• Device Sequence Number: 11541871
• Product Code: QRU
• UDI-Device Identifier: 07290019087021
• UDI-Public: 07290019087021
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P210034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: AGILI-C 7.5MM
• Device Catalogue Number: CH-125
• Device Lot Number: 125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2018
• 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: Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White