MAUDE Adverse Event Report: ONKOS SURGICAL MY3D PERSONALIZED PELVIC RECONSTRUCTION SYSTEM; CANCELLOUS BONE SCREW

Model Number	PV-ACREC-04M
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an onkos pelvic reconstruction case experienced an alleged infection.The patient underwent a revision procedure on (b)(6) 2025 to explant the pelvic reconstruction.This report captures the pelvic implant.This event will be reported as a serious injury due to the explantation.This report captures the pelvic implant.
Additional Manufacturer Narrative
It was reported that the patient implanted with an onkos my3d personalized solutions pelvic case (b)(4)had an alleged infection.The patient has had a history of chronic infection.The patient underwent a procedure on (b)(6) 2025 to explant the devices due to the infection.Device history records could not be reviewed for the my3d personalized pelvic reconstruction screws, as the lot numbers are unknown.Based on the available information, the root cause of the patient's alleged infection could not be determined.Note: initial submission was corrected with surgeon, case, and device information.Incorrect event was initially submitted.
Event or Problem Description
It was reported that a patient with an onkos personalized pelvic reconstruction case experienced an alleged infection.The patient underwent a revision procedure to explant the construct.This event will be reported as a serious injury due to the explantation.This report captures one of the nine explanted bone screws.

• Brand Name: MY3D PERSONALIZED PELVIC RECONSTRUCTION SYSTEM
• Common Device Name: CANCELLOUS BONE SCREW
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey road; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 22985390
• Report Number: 3013450937-2025-00175
• Device Sequence Number: 9709249
• 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): 09/29/2025

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: 10/08/2025
• Device Model Number: PV-ACREC-04M
• Device Lot Number: C25-0270
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 09/29/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male