MAUDE Adverse Event Report: HOLOGIC, INC SECURMARK FOR ATEC; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number	SMARK-ATEC-13-12
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record (dhr) review was unable to be conducted for the device at the time of this report.A follow-up report will follow with the information from the dhr.
Event or Problem Description
It was reported by the user that during their second breast biopsy case on (b)(6) 2026, using a securmark for atec disposable device, marker migration was observed.The user reports that "it appears that the marker migration occurred after the marker had been placed in the final intended position." the user further reports that the marker "appeared to be in the correct location directly after the post marker placement image was taken on the stereotactic unit but showed a 4 cm lateral migration on the post procedure images." it is reported that there was no patient harm; however, the marker placement process was aborted.No further information is currently available.

• Brand Name: SECURMARK FOR ATEC
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 25209101
• Report Number: 1222780-2026-00292
• Device Sequence Number: 8963733
• Product Code: NEU
• UDI-Device Identifier: 05420045503437
• UDI-Public: 05420045503437
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K072913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2026

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: SMARK-ATEC-13-12
• Device Catalogue Number: SMARK-ATEC-13-12
• Device Lot Number: 2509211A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2025
• 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