MAUDE Adverse Event Report: CARBON MEDICAL TECHNOLOGIES BIOMARC FIDUCIAL MARKER; Accelerator, linear, medical

Catalog Number	040142
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Local Reaction (2035)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Biomarc ex fiducial marker is a sterile, pyrogen free, single patient use, pyrolytic carbon coated discrete marker that is visible on standard radiographs and magnetic resonance imaging (mri).Biomarc fiducial markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.Biomarc ex fiducial marker is supplied pre-loaded in a delivery device.There are no known contraindications for biomarc fiducial markers.No testing on the specific device has been conducted as the device was not returned for evaluation.A review of the device history record for this specific lot could not be performed because there was no lot number available associated with this complaint.Upon release, every lot is reviewed and certified to have met all specification requirements.Biocompatibility testing was conducted as part of the initial qualification of this device and was determined to be nonimmunogenic.Although it could not be concluded that this device caused or contributed to this event, it has been determined to be reportable pursuant to 21 cfr 803 due to the reported adverse event.As such, we are submitting this medwatch report.The information contained herein is being provided to fda to comply with regulations relating to medical device reporting and is based on information submitted by others that may not be factually correct.This submission does not constitute a determination or admission that a device has malfunctioned or that a device is related to a death or injury.
Event or Problem Description
A retrospective chart review study reported that a patient experienced an immune response with with a possible association.The event resolved with medical management.The patient had a full recovery.

• Brand Name: BIOMARC FIDUCIAL MARKER
• Common Device Name: Accelerator, linear, medical
• Manufacturer (Section D): CARBON MEDICAL TECHNOLOGIES; 1290 hammond rd; st. paul MN 55110
• Manufacturer Contact: tina wittchow ; 1290 hammond rd; st. paul, MN 55110 ; 6516538512
• MDR Report Key: 19828934
• Report Number: 2134494-2024-00019
• Device Sequence Number: 20844726
• Product Code: IYE
• UDI-Device Identifier: 00858015005080
• UDI-Public: 00858015005080
• Combination Product (Y/N): N
• PMA/510(K) Number: K132064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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 Catalogue Number: 040142
• 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: 06/19/2024
• Initial Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male