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

Model Number	SMARK-M-SS3
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot number.The device was released meeting all qa specifications.
Event or Problem Description
It was reported that a securmark stoplight mri clip was placed in a patient's breast on (b)(6) 2026, and the correct location/placement was confirmed under mammo.It is further reported that after the procedure, while the patient was at home, the encasement surrounding the clip came out of the patient's breast.The user site reports that the encasement was removed by the physician and reimaging was done, which confirmed that the clip itself remained in the correct position.No patient harm was reported; however, injury mdr is being submitted due to the additional interventions that were required.

• Brand Name: SECURMARK MRI
• 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: 25348887
• Report Number: 1222780-2026-00340
• Device Sequence Number: 10741966
• Product Code: NEU
• UDI-Device Identifier: 05420045503994
• UDI-Public: (01)05420045503994(17)260929(10)E25J29RA
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K102608
• 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): 06/01/2026

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 Expiration Date: 09/29/2026
• Device Model Number: SMARK-M-SS3
• Device Catalogue Number: SMARK-M-SS3
• Device Lot Number: E25J29RA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown