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

Model Number	HB100
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
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 a localizer procedure on (b)(6) 2025, the user experienced issues with the device "going off constantly" even when it is not near a clip.Additionally, the user reported that clip migration issues have been experienced.Malfunction mdr submitted due to reports of clip migration.The user reports four impacted devices; therefore, a separate mdr will be submitted for each device.No patient/user injury has been reported.No further information is currently available.
Additional Manufacturer Narrative
An investigation was conducted: it was reported by the user that during a localizer procedure on (b)(6) 2025, the user experienced issues with the device "going off constantly" even when it is not near a clip.Additionally, the user reported that clip migration issues have been experienced.Malfunction mdr submitted due to reports of clip migration.No patient/user injury has been reported.Initial evaluation: the device was returned to the post market quality laboratory for investigation.Visual inspection was conducted and there were no signs of physical damage.Investigation methods and findings: functional testing was conducted, and no power issues were present.However, the device did not read the distances as intended using the loop probe; therefore, the complaint can be confirmed.Cause/root cause: the complaint was confirmed based on the observed incorrect distance measurement during functional testing.While the device met all acceptance criteria at the time of release per device history record (dhr) review, the observed behavior in the functional test indicates a malfunction in the reader¿s ability to detect and/or process distance signals from the loop probe.A definitive root cause could not be established based on the available evidence; however, the most probable cause is associated with a failure in the reader¿s signal detection or processing functionality, leading to inaccurate distance readings.Conclusion: the reported issue of inaccurate distance reading has been confirmed; however, a definitive root cause could not be established.The most probable root cause is associated with a failure in the reader¿s signal detection or processing functionality, leading to inaccurate distance readings.A conclusion could not be reached regarding the report of tag migration.Capa/hra/ncr/scar are not deemed required at this moment by this event.Future events will be monitored and trended.Complaint confirmed: yes device history record (dhr) review: the dhr was reviewed for the corresponding lot, and no non-conformance or deviations were found.

• Brand Name: LOCALIZER
• 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: 24058909
• Report Number: 1222780-2026-00022
• Device Sequence Number: 13232547
• Product Code: NEU
• UDI-Device Identifier: 00855436007037
• UDI-Public: (01)00855436007037(21)022488095(11)240220
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 04/09/2026

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: HB100
• Device Catalogue Number: HB100
• Device Lot Number: 50177458-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown