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

Catalog Number	PV-ACREC-04M
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was difficulty implanting an onkos pelvic reconstruction implant, resulting in the surgeon using an alternate pelvic implant.The procedure was completed successfully with the alternate device.This event will be reported to the fda as a malfunction.
Additional Manufacturer Narrative
It was reported that during the procedure for the patient specific case, the surgeon was unable to use the implant.The procedure was initially scheduled for (b)(6) 2024; however, the patient became infected and required additional time to clear the infection.The surgery was rescheduled to (b)(6) 2025.The surgeon was not able to get the implant to fit with patient anatomy intraoperatively.The surgeon switched to an off the shelf large multi-hole cup.The delay in completing the surgery was said to be insignificant, less than 30 minutes.Device history records were reviewed for pv-acrec-04m, lot c24-0701, and no manufacturing abnormalities were discovered.All dimensional inspections were within specification.The root cause of this event could not be identified based on the available information.

• Brand Name: MY3D PELVIC RECONSTRUCTION SYSTEM
• Common Device Name: ACETABULAR RECONSTRUCTION IMPLANT
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey road; parsippany NJ 07054
• Manufacturer Contact: yara neurauter ; 77 e halsey road; parsippany 07054
• MDR Report Key: 21998451
• Report Number: 3013450937-2025-00097
• Device Sequence Number: 9447035
• Product Code: LPH
• UDI-Device Identifier: B278PVACREC04M0
• UDI-Public: B278PVACREC04M0
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PV-ACREC-04M
• Device Lot Number: C24-0701
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown