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

Catalog Number	LS-50040-04M
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation for this event is in progress.Once the investigation is complete, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that a patient implanted with a custom onkos intercalary tibia construct experienced subsidence at the proximal portion.The patient's index procedure took place on (b)(6) 2024.The patient was revised on (b)(6) 2024 to augment the proximal portion with bone cement and replace the four proximal screws.This event will be reportable as a serious injury, due to the revision procedure.This report captures the my3d personalized pelvic reconstruction cortical locking bone screw, fourth of the four proximal screws.

• Brand Name: MY3D PERSONALIZED PELVIC RECONSTRUCTION SYSTEM
• Common Device Name: CORTICAL LOCKING BONE SCREW
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey road; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey road; parsippany, NJ 07054
• MDR Report Key: 20903401
• Report Number: 3013450937-2024-00407
• Device Sequence Number: 5004795
• Product Code: LPH
• UDI-Device Identifier: B278LS5004004M0
• UDI-Public: B278LS5004004M0
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K223348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/11/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: LS-50040-04M
• 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: 11/11/2024
• Initial Report FDA Received Date: 12/11/2024
• 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: 55 YR
• Patient Sex: Male