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

Catalog Number	PV-ACREC-04M
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Clinical Signs, Symptoms or Conditions (4582); Medical device site infection (4845)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information regarding this event is not known at this time.When additional information is received, a supplemental will be filed accordingly.
Event or Problem Description
It was reported that the patient's my3d personalized pelvic reconstruction acetabular implant loosened.The patient's index procedure occurred on (b)(6) 2023, and the patient was revised on (b)(6) 2023.Details regarding the revision surgery are not known at this time.This event will be reportable to the fda as a serious injury due to the revision procedure.
Additional Manufacturer Narrative
It was reported by p.Medina, an onkos sales representative, that the 64-year-old female patient fell, and the force of the fall caused the acetabular reconstruction implant to loosen.A revision surgery to properly fixate the implant took place on (b)(6) 2023, during which the surgeon discovered that there was an infection.The implant and all related hardware were subsequently explanted, and steps were taken to eliminate the infection.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 joint infection and trauma-related loosening was not related to the design, manufacture, and/or sterilization of the pelvic implant.The following mdrs are related to this adverse event: 3013450937-2024-00003, 3013450937-2024-00042 (added per investigation), 3013450937-2024-00043 (added per investigation), 3013450937-2024-00044 (added per investigation), 3013450937-2024-00045 (added per investigation), 3013450937-2024-00046 (added per investigation), 3013450937-2024-00047 (added per investigation).
Event or Problem Description
It was reported by p.Medina, an onkos sales representative, that the 64-year-old female patient fell, and the force of the fall caused the acetabular reconstruction implant to loosen.A revision surgery to properly fixate the implant took place on (b)(6) 2023, during which the surgeon discovered that there was an infection.The implant and all related hardware were subsequently explanted, and steps were taken to eliminate the infection.The primary surgery to insert the acetabular reconstruction implant took place on (b)(6) 2023.The patient reportedly fell approximately one month after the primary surgery date.

• Brand Name: MY3D PERSONALIZED PELVIC RECONSTRUCTION
• Common Device Name: ACETABULAR RECONSTRUCTION IMPLANT
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer Contact: yara neurauter ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 18451230
• Report Number: 3013450937-2024-00003
• Device Sequence Number: 12707856
• Product Code: LPH
• UDI-Device Identifier: B278PVACREC04M0
• UDI-Public: B278PVACREC04M0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2023
• 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,Followup
• Report Date (Section B): 03/01/2024

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 Expiration Date: 02/29/2024
• Device Catalogue Number: PV-ACREC-04M
• Device Lot Number: C23-529
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACETABULAR RECONSTRUCTION IMPLANT; CANCELLOUS BONE SCREW, 6.5MM DIA X 15MM LENGTH; CANCELLOUS BONE SCREW, 6.5MM DIA X 15MM LENGTH; CANCELLOUS BONE SCREW, 6.5MM DIA X 20MM LENGTH; CANCELLOUS BONE SCREW, 6.5MM DIA X 20MM LENGTH; CANCELLOUS BONE SCREW, 6.5MM DIA X 55MM LENGTH; CANCELLOUS BONE SCREW, 6.5MM X 65MM LENGTH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female