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

Model Number PV-ACREC-04M

Device Problems Material Discolored (1170); Insufficient Information (3190); Unexpected Color (4055)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2023

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 321978910
• Report Number: 3013450937-2023-00185
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: B278PVACREC04M0
• UDI-Public: B278PVACREC04M0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male