MAUDE Adverse Event Report: SOMATEX MEDICAL TECHNOLOGIES GMBH TUMARK VISION; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number	271590
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a breast biopsy procedure on (b)(6) 2025, the user placed a tumark vision breast marker into the breast of a patient "without problems." it is further reported that the user later needed to acquire extra biopsies from the same area and it appears that the biopsy needle broke the previously placed tumark vision marker.The user reports that no further biopsy procedures are required for this patient and the tumark vision marker can remain in the patients breast.No further information is currently available.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported.

• Brand Name: TUMARK VISION
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): SOMATEX MEDICAL TECHNOLOGIES GMBH; kaiserin-augusta-allee 112/113; berlin, 10553 ; GM 10553
• Manufacturer (Section G): SOMATEX MEDICAL TECHNOLOGIES GMBH; kaiserin-augusta-allee 112/113; berlin, 10553 ; GM 10553
• Manufacturer Contact: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 24019746
• Report Number: 3030927217-2026-00001
• Device Sequence Number: 10590951
• Product Code: NEU
• UDI-Device Identifier: 04250195607836
• UDI-Public: (01)04250195607836(17)290610(11)240611(10)53331
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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: 271590
• Device Catalogue Number: 271590
• Device Lot Number: 53331
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2024
• 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: Unknown