MAUDE Adverse Event Report: ONKOS SURGICAL INC MY3D PERSONALIZED PELVIC RECONSTRUCTION; CANCELLOUS BONE SCREW, 6.5MM DIA X 50MM LENGTH

Catalog Number	CS-65050-04M
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
It was reported that a patient had an alleged infection and underwent a revision procedure to explant onkos devices.The explanted devices were not returned for additional evaluation.Production records could not be reviewed for the device captured in this report as the lot number is unknown.Based on the available information, the root cause of the event could not be determined.The following mfrs were submitted for the devices involved in this event: 3013450937-2024-00093 3013450937-2024-00094 3013450937-2024-00095 3013450937-2024-00097 3013450937-2024-00098 3013450937-2024-00099 3013450937-2024-00100 3013450937-2024-00101 3013450937-2024-00102 3013450937-2024-00103 3013450937-2024-00104 3013450937-2024-00105 3013450937-2024-00106.
Event or Problem Description
It was reported that a patient had an alleged infection and underwent a revision procedure to explant onkos devices.The patient's primary surgery occured on (b)(6) 2023, where the patient was implanted with a my3d pelvic implant, which was approved through the compassionate use pathway.The patient was also implanted with my3d personalized pelvic reconstruction cancellous bone screws, my3d personalized pelvic reconstruction locking cortical bone screws, and a my3d personalized pelvic reconstruction apical hole plug.As the patient underwent a revision procedure, this event will be reportable to the fda as a serious injury.This report captures a my3d personalized pelvic reconstruction cancellous bone screw.

• Brand Name: MY3D PERSONALIZED PELVIC RECONSTRUCTION
• Common Device Name: CANCELLOUS BONE SCREW, 6.5MM DIA X 50MM LENGTH
• Manufacturer (Section D): ONKOS SURGICAL INC; 77 e halsey rd; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany 07054
• MDR Report Key: 19098096
• Report Number: 3013450937-2024-00096
• Device Sequence Number: 15310517
• Product Code: LPH
• UDI-Device Identifier: B278CS6505004M0
• UDI-Public: B278CS6505004M0
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2024

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-65050-04M
• 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: 04/05/2024
• Initial Report FDA Received Date: 04/12/2024
• 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: 62 YR
• Patient Sex: Female