MAUDE Adverse Event Report: ONKOS SURGICAL MY3D PERSONALIZED PELVIC RECONSTRUCTION SYSTEM; CANCELLOUS BONE SCREW, 6.5X 25MM

Catalog Number	CS-65025-04M
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is pending investigation.Once additonal information is received, a supplemental will be filed accordingly.
Event or Problem Description
It was reported that a patient had an alleged infection and elected to have an amputation.This patient was implanted with a my3d personalized solutions pelvis implant and 10 my3d personalized pelvic reconstruction cancellous bone screws.The patient's index surgery occurred on (b)(6) 2023.All implanted devices were explanted on (b)(6) 2024.This event will be reportable to the fda as a serious injury due to the revision procedure.This report captures one my3d personalized pelvic reconstruction cancellous bone screw.
Additional Manufacturer Narrative
It was reported that the patient had an alleged infection and elected to have an amputation.This patient was implanted with a my3d personalized solutions pelvic implant (cleared through the compassionate use pathway) and my3d personalized pelvic reconstruction system cancellous bone screws.The patient's index surgery occurred on (b)(6) 2023.All implanted devices were explanted on (b)(6) 2024.Additional information regarding this event and devices implanted were not available for investigation, therefore, the root cause of the patient's alleged infection could not be determined.

• Brand Name: MY3D PERSONALIZED PELVIC RECONSTRUCTION SYSTEM
• Common Device Name: CANCELLOUS BONE SCREW, 6.5X 25MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey rd; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 19522200
• Report Number: 3013450937-2024-00180
• Device Sequence Number: 6080993
• Product Code: LPH
• UDI-Device Identifier: B278CS6502504M0
• UDI-Public: B278CS6502504M0
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K212815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 08/12/2024

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 Catalogue Number: CS-65025-04M
• 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: 05/13/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 08/12/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male