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

Catalog Number	PV-ACREC-04M
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This investigation is in process.Once additional information is available, a supplemental mdr will be reported accordingly.
Event or Problem Description
It was reported that during a my3d personalized pelvic reconstruction case, the surgeon had difficulty fitting the implant into the patient anatomy (specifically, getting both the iliac and ischial flanges to fully sit down on bone at the same time).For the implant to have good fit superiorly, the ischial flange was cut off intraoperatively.The surgery was completed successfully with a less than 30 minute surgical delay.This event will be reported to the fda as a malfunction as there is potential for the implant to loosen and contribute to a serious injury in the furture.
Additional Manufacturer Narrative
On (b)(6) 2023, (b)(6) (an onkos engineer) reported that the surgeon, dr (b)(6), experienced difficulty with fitting a my3d® personalized pelvic reconstruction implant into patient anatomy intraoperatively on (b)(6) 2023.More specifically, the surgeon reported a fit issue due to the inability to seat the iliac and ischial flanges on the bone simultaneously.It was decided to remove the ischial flange, which was cut off intraoperatively.The surgery was reportedly completed successfully with a less than 30-minute surgical delay.As detailed in section 3.5, the ifu and surgical technique documentation identifies elements that represent potential contributing factors to the pelvic implant/bone fit issue identified in this complaint.The root cause of this complaint was not determined.Based on the review of device history records, the investigation concluded that the root cause of the pelvic implant/bone fit issue was not related to the design, manufacture, and/or sterilization of the pelvic implant.

• Brand Name: MY3D PERSONALIZED PELVIC RECONSTRUCTION SYSTEM
• Common Device Name: ACETABULAR RECONSTRUCTION IMPLANT
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey rd; parsippany NJ 07054
• Manufacturer (Section G): ONKOS SURGICAL; 77 e halsey rd; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 18315355
• Report Number: 3013450937-2023-00303
• Device Sequence Number: 12290990
• Product Code: LPH
• UDI-Device Identifier: B278PVACREC04M0
• UDI-Public: B278PVACREC04M0
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K212815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2023
• Device Catalogue Number: PV-ACREC-04M
• Device Lot Number: C23-483
• 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: 11/10/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2023
• 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
• Patient Sex: Female