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

Model Number	HB300-05
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a localizer procedure on (b)(6) 2026, the "localizer rfid tag would not emit a signal during surgery.Multiple localizer readers and probes were used to troubleshoot." it was further reported that "radiology confirmed the tag was working prior to placing it and they were able to get a signal of the tag once the specimen was out, and very close to it, but no signal inside the breast." reporting indicates that in order to identify the tag location, "they had to bring in a c arm during surgery." no patient harm was reported; however, injury mdr is being submitted due to the additional intervention that was required.
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.

• 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 dr; newark, DE 19702
• MDR Report Key: 50024650
• Report Number: 1222780-2026-00456
• Device Sequence Number: 10579020
• Product Code: NEU
• UDI-Device Identifier: 00855436007143
• UDI-Public: 00855436007143
• 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
• Report Date (Section B): 07/24/2026

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: HB300-05
• Device Catalogue Number: HB300-05
• Device Lot Number: 57059
• 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: 07/16/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown