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

Model 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	04/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery on (b)(6) 2023, a surgeon reported having difficulty fitting an acetabular reconstruction implant into the patient's anatomy.In order to fit the implant into the patient's anatomy, the implant was modified intra-operatively- the ischial flange was cut off using a metal cutting burr, resulting in the implant having only one flange.After modification, the procedure was able to be completed.This event will be reportable to the fda as a malfunction, as the issue could cause or contribute to a serious injury.
Additional Manufacturer Narrative
It was reported that during a my3d personalized pelvic reconstruction case on (b)(6) 2023, the surgeon had difficulty fitting the pelvic implant into patient anatomy.As a result, the ischial flange was cut off with a metal burr intra-operatively to fit the implant into the anatomy.The surgical delay which resulted was under 30 minutes.Ultimately, the implant was able to be placed into the patient and surgery was completed.The patient's anatomy, based on the scan used for design, presented a cavity in the posterior column.The design of the implant, which was approved by the surgeon, attempted to fill the void with a posterior abutment.During intra-operative placement, after removal of the hardware, the cavity was not present which resulted in the implant not matching the patient's anatomy.It is possible that the removal of previously implanted hardware created a change in anatomy which was not accurately accounted for during the design phase.Alternatively, artifacts from the previously implanted hardware in the scan data could have impacted the design of the device.Review of the my3d pelvic reconstruction system ifu identified the following excerpt, "prior hardware can create various degrees of artifact that may compromise the surgeon-engineer design team from identifying bone of poor quality.This failure to identify bone of sufficient quality can lead to improper fit of the custom component as well as early loosening if fit or bone quality is inadequate".

• Brand Name: MY3D PERSONALIZED PELVIC RECONSTRUCTION
• Common Device Name: ACETABULAR RECONSTRUCTION IMPLANT
• 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: 16924602
• Report Number: 3013450937-2023-00075
• Device Sequence Number: 12495181
• Product Code: LPH
• UDI-Device Identifier: B278PVACREC04M0
• UDI-Public: B278PVACREC04M0
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/10/2023

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: 06/29/2023
• Device Model Number: PV-ACREC-04M
• Device Catalogue Number: PV-ACREC-04M
• Device Lot Number: C23-021
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female