MAUDE Adverse Event Report: RESTOR3D, INC. KINOS PSR; PATIENT SPECIFIC INSTRUMENTATION

Model Number	1834-0140
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient required a revision surgery following a tar implanted with psr in (b)(6) 2025.Imaging revealed that the tibial implant had subsided and that cystic formations were present in the distal tibia surrounding stem fixation.
Additional Manufacturer Narrative
Analysis of production records reveals no abnormalities in the manufacturing or design of the device in question.The information provided by the reporter, including patient imaging, was reviewed.The development of cysts affecting fixation in the distal tibia is the most likely cause of the implant loosening, as they were not present in the scans used for design of the psi.

• Brand Name: KINOS PSR
• Common Device Name: PATIENT SPECIFIC INSTRUMENTATION
• Manufacturer (Section D): RESTOR3D, INC.; 4001 nc hwy 54; ste 3160; durham NC 27709
• Manufacturer (Section G): RESTOR3D, INC.
• Manufacturer Contact: brianna gabbard ; 4001 nc hwy 54; ste 3160; durham, NC 27709
• MDR Report Key: 25512143
• Report Number: 3014833750-2026-00017
• Device Sequence Number: 16099357
• Product Code: OYK
• UDI-Device Identifier: 00840097509259
• UDI-Public: 00840097509259
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2026

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
• Device Model Number: 1834-0140
• Device Lot Number: 2024110017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 06/15/2026
• 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