MAUDE Adverse Event Report: RESTOR3D, INC. ITOTAL IDENTITY CR; CRUCIATE RETAINING TOTAL KNEE REPLACEMENT

Model Number	ED-08081
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the tibial implant of a total knee system was implanted in such a way that there was interference between the device and a screw in the patellar tendon, suggesting that there was excessive slope in the way the tibial implant was implanted.The device is not available for evaluation, and it is not presently clear which model or version of the device is in scope of this adverse event.Additional information that becomes available will be submitted via follow-up as it becomes available.
Event or Problem Description
It was reported that the tibial implant of a total knee system was implanted in such a way that there was interference between the device and a screw in the patellar tendon, suggesting that there was excessive slope in the way the tibial implant was implanted.
Additional Manufacturer Narrative
It was reported that the tibial implant of a total knee system was implanted in such a way that there was interference between the device and a screw in the patellar tendon, suggesting that there was excessive slope in the way the tibial implant was implanted.The device is not available for evaluation, and it is not presently clear which model or version of the device is in scope of this adverse event.Additional information that becomes available will be submitted via follow-up as it becomes available.Improper implant placement is a well-known risk of total knee replacement and could be caused by improper jig design or introperative error by the user.Discussion with the user indicates improper cut location during jig use may have been caused by misuse or improper instrument seating during surgery.Analysis of production records and design records reveals no abnormality that could have contributed to the subject adverse event.
Event or Problem Description
It was reported that the tibial implant of a total knee system was implanted in such a way that there was interference between the device and a screw in the patellar tendon, suggesting that there was excessive slope in the way the tibial implant was implanted.

• Brand Name: ITOTAL IDENTITY CR
• Common Device Name: CRUCIATE RETAINING TOTAL KNEE REPLACEMENT
• Manufacturer (Section D): RESTOR3D, INC.; 600 research drive; wilmington MA 01887
• Manufacturer (Section G): RESTOR3D, INC.; 600 research drive; wilmington MA 01887
• Manufacturer Contact: brianna prindle ; 4001 nc hwy 54; ste 3160; durham, NC 27709
• MDR Report Key: 25116584
• Report Number: 3014833750-2026-00104
• Device Sequence Number: 16017140
• Product Code: MBH
• UDI-Device Identifier: M572TCR1011112011
• UDI-Public: M572TCR1011112011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K243768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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: ED-08081
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 05/13/2026
• 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