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

Model Number	SMARK-EVIVA-2S-13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Breast Discomfort/Pain (4504)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It reported that a patient received a securmark breast marker on an unknown date in 2016.The patient reports that "worsening pain" was experienced; therefore, the marker was removed on an unknown date in 2017.No further information is currently available.
Additional Manufacturer Narrative
An investigation was conducted: investigation methods and findings: the device was not available for return; visual and functional analysis/testing could not be conducted for the described event.Cause/root cause: the sample was not returned for this complaint and there was limited patient-related information provided for this event.Investigation for this issue was conducted through customer provided information, historical data review, similar complaints analysis, and product design evaluation.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.Complaint confirmed: no.Device history record (dhr) review not performed.No lot number was provided; therefore, no dhr could be located or reviewed.

• Brand Name: SECURMARK
• 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: 24650259
• Report Number: 1222780-2026-00133
• Device Sequence Number: 9760741
• Product Code: NEU
• UDI-Device Identifier: 05420045503628
• UDI-Public: 05420045503628
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062528
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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 Model Number: SMARK-EVIVA-2S-13
• Device Catalogue Number: SMARK-EVIVA-2S-13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown