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

Catalog Number	PV-ACREC-04M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history records were reviewed for pv-acrec-04m, lot c25-0216 and no manufacturing abnormalities were discovered.All dimensional inspections were within specification.Nonconformance history was reviewed for this case, and no nonconformances were identified.Upon further communication with the field representative, it was reported that the patient had an underlying condition that was not known at the time of planning or surgery, which caused the bone to be significantly less reliable than planned for.This likely resulted in an inability to seat the patient-specific implant in the optimal/planned position; however, a root cause could not be established conclusively.
Event or Problem Description
It was reported that an onkos acetabular pelvic implant designed in case (b)(4) was unable to fit into the patient's anatomy; therefore, an off-the-shelf option was used instead.The length of surgical delay is not known.This event will be reported as a malfunction, as the event could have contributed to a serious injury.

• Brand Name: MY3D PERSONALIZED PELVIC RECONSTRUCTION SYSTEM
• Common Device Name: ACETABULAR RECONSTRUCTION IMPLANT
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey road; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; parsippany, NJ
• MDR Report Key: 22841636
• Report Number: 3013450937-2025-00166
• Device Sequence Number: 20039483
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2025

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: C25-0216
• 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: 05/22/2025
• Initial Report FDA Received Date: 08/19/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown