MAUDE Adverse Event Report: ONKOS SURGICAL MY3D PERSONALIZED PELVIC RECONSTRUCTION SYSTEM; APLICAL HOLE PLUG

Model Number	AP-38016-04M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient implanted with my3d pelvis case (b)(4) had an alleged infection.The patient received a washout procedure- no devices were explanted during this procedure.The root cause of the patient's alleged infection could not be determined based on available information.The following mdr submissions are a part of this event: 3013450937-2025-00174, 3013450937-2025-00216, 3013450937-2025-00217, 3013450937-2025-00218, 3013450937-2025-00219, 3013450937-2025-00220, 3013450937-2025-00221, 3013450937-2025-00222, 3013450937-2025-00223, 3013450937-2025-00224, 3013450937-2025-00225, 3013450937-2025-00226, 3013450937-2025-00227.
Event or Problem Description
On (b)(6) 2025: the patient implanted with my3d pelvic reconstruction system case (b)(4) had an alleged infection.The patient received a washout procedure- no devices were explanted during this procedure.

• Brand Name: MY3D PERSONALIZED PELVIC RECONSTRUCTION SYSTEM
• Common Device Name: APLICAL HOLE PLUG
• 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: 23067606
• Report Number: 3013450937-2025-00228
• Device Sequence Number: 15904883
• Product Code: LPH
• UDI-Device Identifier: B278AP3801604M0
• UDI-Public: B278AP3801604M0
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 09/16/2025

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 Model Number: AP-38016-04M
• 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: 09/15/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female