MAUDE Adverse Event Report: ONKOS SURGICAL MY3D PERSONALIZED PELVIC RECONSTRUCTION IMPLANT; 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	05/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This investigation is ongoing.Once additional information is received, a supplemental will be submitted accordingly.
Event or Problem Description
It was reported on (b)(6) 2023 that a my3d personalized pelvic reconstruction implant was unable to fit as intended, due to issues removing previous hardware.The previous hardware was an augment from another company which was intended to be removed, but it was left in the patient as it was difficult to remove intra-operatively.As a result, the acetabular reconstruction implant was slightly proud of the intended location.The procedure was able to be completed successfully.This event will be reportable to the fda as a malfunction, as the issue could cause or contribute to a serious injury in the future.
Event or Problem Description
It was reported on (b)(6) 2023 that a my3d personalized pelvic reconstruction implant was unable to fit as intended, due to issues removing previous hardware.The previous hardware was an augment from another company which was intended to be removed, but it was left in the patient as it was difficult to remove intra-operatively.As a result, the acetabular reconstruction implant was slightly proud of the intended location.The procedure was able to be completed successfully with a 45 minute surgical delay.This event will be reportable to the fda as a malfunction, as the issue could cause or contribute to a serious injury in the future.
Additional Manufacturer Narrative
It was reported that during a my3d pelvic reconstruction case (c23-087) on (b)(6) 2023, there was difficulty placing the acetabular reconstruction implant.The patient had previously implanted hardware from a different company - acetabular cup, augment, acetabular cement, screws, posterior plates, floating bone.The patient was reported to have sclerotic bone.It was reported that a previously implanted augment could not be removed and was left in the patient.Additionally, the recommended posterior lateral approach in the design proposal was not used- the surgeon operated laterally.The procedure was completed with a 45-minute surgical delay.The patient had previously implanted hardware from a different company - acetabular cup, augment, acetabular cement, screws, posterior plates, floating bone.It was reported that a previously implanted augment could not be removed and was left in the patient.As the previously implanted augment was left in the patient, it likely caused difficulty fitting the patient matched implant into the patient, as it was designed with the intention of all previous hardware being removed.According to the case plan for c23-087, "all existing pelvic hardware and cement to be removed- acetabular cup, augment, existing acetabular cement, screws, posterior plates, floating bone." additionally, the recommended posterior lateral approach in the design proposal was not used- the surgeon operated laterally.Operating from a different plane than originally planned can also contribute to difficulty during implantation.

• Brand Name: MY3D PERSONALIZED PELVIC RECONSTRUCTION IMPLANT
• Common Device Name: ACETABULAR RECONSTRUCTION IMPLANT
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey road; parsipanny NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey road; parsippany, NJ 07054
• MDR Report Key: 17101184
• Report Number: 3013450937-2023-00097
• Device Sequence Number: 15376172
• Product Code: LPH
• UDI-Device Identifier: B278PVACREC04M0
• UDI-Public: B278PVACREC04M0
• 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
• 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): 09/08/2023

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 Model Number: PV-ACREC-04M
• Device Catalogue Number: PV-ACREC-04M
• Device Lot Number: C22-087
• 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: 05/12/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 09/08/2023
• Date Device Manufactured: 04/25/2023
• 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: Required Intervention
• Patient Sex: Unknown