MAUDE Adverse Event Report: ONKOS SURGICAL INC. MY3D PERSONALIZED PELVIC RECONSTRUCTION SYSTEM; ACETABULAR RECONSTRUCTION IMPLANT

Catalog Number	PV-ACREC-04M
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause of this complaint was not determined.Based on the review of known device history records, the investigation concluded that the root cause of the alleged infection was not related to the design, manufacture, and/or sterilization of the revised implants.
Event or Problem Description
It was reported that a patient implanted with an eleos distal femur replacement was revised on (b)(6) 2025 due to an alleged infection.This report captures the eleos poly spacer.This event will be reported as a serious injury due to the revision procedure.
Additional Manufacturer Narrative
Device history records were reviewed for pv-acrec-04m, lot c24-0238, and no manufacturing abnormalities were discovered.All dimensional inspections were within specification.Nonconformance history was reviewed for this case, and no nonconformances were identified.The root cause of this event could not be identified based on the available information.The following corrections were made from the intiail mdr submission- a1, b2, b3, b4, b5, d1, d2, d4, g3, g6, g4, h2, h6, h10- as incorrect information was initially provided.All content was corrected in this report.
Event or Problem Description
It was reported that the pelvic implant designed in case(b)(4) was unable to fit into the patient's anatomy; therefore, an off-the-shelf option was implanted instead.This event resulted in approximately 60-minute delay.This report captures the my3d personalized pelvic recontruction implant.This event will be reported to the fda as a serious injury due to the 60-minute surgical delay.

• Brand Name: MY3D PERSONALIZED PELVIC RECONSTRUCTION SYSTEM
• Common Device Name: ACETABULAR RECONSTRUCTION IMPLANT
• Manufacturer (Section D): ONKOS SURGICAL INC.; 77 e halsey rd; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany 07054
• MDR Report Key: 22309904
• Report Number: 3013450937-2025-00130
• Device Sequence Number: 15474223
• Product Code: LPH
• UDI-Device Identifier: B278PVACREC04M0
• UDI-Public: B278PVACREC04M0
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K212815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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 Expiration Date: 09/26/2025
• Device Catalogue Number: PV-ACREC-04M
• Device Lot Number: C25-0238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2024
• 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; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female