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

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
Additional Manufacturer Narrative
Additional informaion is not available at this time.If additional information is recieved, a supplemental will be submitted accordingly.
Event or Problem Description
It was reported that a patient with an onkos pelvic reconstruction case experienced an alleged infection.Additional details are not known at this time.
Event or Problem Description
(b)(6) 2025 update: 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.
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: 3013450937-2025-00216 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 3013450937-2025-00228.

• 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 ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 22985216
• Report Number: 3013450937-2025-00174
• Device Sequence Number: 15696477
• Product Code: LPH
• UDI-Device Identifier: B278PVACREC04M0
• UDI-Public: B278PVACREC04M0
• 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,Followup
• 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: PV-ACREC-04M
• Device Lot Number: C25-0222
• 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: 09/15/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement 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