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	Foreign Body In Patient (2687)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, following a patient´s operation an x-ray of the specimen removed from the patient, revealed that a piece of the material used to insert the clip was also present in the tumor additionally to the clip.The piece of material was there since implantation on (b)(6) 2024.There were no noticeable incidents during the examination apart some resistance when removing the material to insert the clip.No patient injury reported and no medical intervention required.
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.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
Additional Manufacturer Narrative
An investigation was conducted: it was reported that on (b)(6) 2024, following a patient´s operation an x-ray of the specimen removed from the patient, revealed that a piece of the material used to insert the clip was also present in the tumor additionally to the clip.The piece of material was there since implantation on (b)(6) 2024.There were no noticeable incidents during the examination apart from some resistance when removing the material to insert the clip.No patient injury reported, and no medical intervention required.The device was not available for return; visual and functional analysis/testing could not be conducted for the described event.The sample was not returned for this complaint and there was limited patient-related information provided for this event; therefore, a thorough investigation was not carried out.Investigation for this issue was conducted through customer provided information, historical data review, similar complaints analysis, and product design evaluation.Without the returned sample, it is not possible to confirm a definitive root cause of the issue.Conclusion: the reported issue could not be confirmed because the device was not returned.Capa/hra/ncr/scar are not deemed required at this moment by this event.Future events will be monitored and trended.Device history record (dhr) review: a device history record (dhr) review was conducted for the reported lot/serial 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: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102
• MDR Report Key: 20835876
• Report Number: 1222780-2024-00462
• Device Sequence Number: 8585186
• Product Code: NEU
• UDI-Device Identifier: 15420045503304
• UDI-Public: (01)15420045503304(17)260612(10)E24F12RA
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K023450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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 Expiration Date: 06/12/2026
• Device Model Number: TRIMARK TD 3609
• Device Catalogue Number: TRIMARK TD 3609
• Device Lot Number: E24F12RA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown