MAUDE Adverse Event Report: ONKOS SURGICAL MY 3D PERSONALIZED SOLUTIONS; ACETABULAR RECONSTRUCTION IMPLANT

Model Number	PV-ACREC-04M
Medical Device Problem Codes	Material Discolored (1170); Insufficient Device Problem Information (3190); Unexpected Color (4055)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is in process.The device will not be returned for evaluation.When the investigation is complete, a supplemental mdr will be submitted accordingly.
Event or Problem Description
It was reported that a pelvic implant was observed to be discolored post-sterilization at the hospital for a surgery on (b)(6) 2023.It was reported that the metal implant was sterilized with the plastic components.The device was implanted in the patient during this procedure.No further information has been made available.
Additional Manufacturer Narrative
It was reported that the pelvic implant and anatomic models for a my3d pelvic reconstruction case on (b)(6) 2023 were sterilized together.Discoloration was reported to be seen on the implant post sterilization.The procedure was able to be completed successfully.No surgical delay was caused by this issue.Visual, dimensional, functional and material analysis could not be conducted as the part was implanted.Production records were reviewed, all manufacturing and associated inspections were completed successfully.Sterilization batch record review was not performed as these implants and accessories are provided nonsterile.These parts undergo sterilization at the hospital prior to surgery.The my3d personalized pelvic reconstruction ifu specifies that the metal implant and plastic accessories should not be sterilized together, which likely contributed to this issue.

• Brand Name: MY 3D PERSONALIZED SOLUTIONS
• 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: sara dailey ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 17625143
• Report Number: 3013450937-2023-00185
• Device Sequence Number: 12583617
• Product Code: LPH
• UDI-Device Identifier: B278PVACREC04M0
• UDI-Public: B278PVACREC04M0
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/04/2023

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: 12/09/2023
• Device Model Number: PV-ACREC-04M
• Device Catalogue Number: PV-ACREC-04M
• Device Lot Number: C23-075
• 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: 07/28/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2023
• 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: Male