MAUDE Adverse Event Report: Hologic, Inc. TRIMARK; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number	TRIMARK TD 3609
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on july 20, 2026 that during a procedure with a trimark that "when the marker was used on a patient and inserted into the patient's breast, it opened and came apart, leaving a small piece of the marker inside the patient.".Customer outreach was performed and confirmed the patient did not suffer any additional harm, and there was no additional medical or surgical intervention required as a result of the retained fragment.There are no post-procedure images available and no further information is available at this time.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot number.The device was released meeting all qa specifications.

• Brand Name: TRIMARK
• 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: sarah lawlor ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 50165687
• Report Number: 1222780-2026-00476
• Device Sequence Number: 12081961
• Product Code: NEU
• UDI-Device Identifier: 05420045503307
• UDI-Public: (01)05420045503307(17)270802(10)E25H02RJ
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• PMA/510(K) Number: K023450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TRIMARK TD 3609
• Device Catalogue Number: TRIMARK TD 3609
• Device Lot Number: E25H02RJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2025
• 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