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

Model Number	F0303
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Breast Discomfort/Pain (4504)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Hologic has received correspondence arising from litigation.The litigation alleges that a 53-year-old patient was implanted on (b)(6) 2024 with a biozorb marker following a surgical procedure for a right breast lumpectomy.On (b)(6) 2025 patient presented with concerns related to the right breast tissue pain asking to be evaluated for infection.Patient endorsed presence of right breast pain since (b)(6) 2024.On (b)(6) 2025 the patient underwent a surgical intervention for biozorb removal.The implant was found partially absorbed, and in 2 separate pieces which were removed from the surrounding breast tissue.No other relevant information was provided.This report is being submitted pursuant to 21 cfr part 803 based on information made available to hologic through litigation.Consistent with 21 cfr 803.16, the submission of this report is not intended, and shall not be construed, as an admission, acknowledgment, or confirmation by hologic that the device caused or contributed to the reportable event.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot number.The device was released meeting all qa specifications.This report is being submitted pursuant to 21 cfr part 803 based on information made available to hologic through litigation.Consistent with 21 cfr 803.16, the submission of this report is not intended, and shall not be construed, as an admission, acknowledgment, or confirmation by hologic that the device caused or contributed to the reportable event.

• Brand Name: BIOZORB
• 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: 25271156
• Report Number: 1222780-2026-00328
• Device Sequence Number: 13057864
• Product Code: NEU
• UDI-Device Identifier: 15420045514003
• UDI-Public: (01)15420045514003(17)260119(10)23H03RA
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2026

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 Expiration Date: 01/19/2026
• Device Model Number: F0303
• Device Catalogue Number: F0303
• Device Lot Number: 23H03RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Supplement Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 05/25/2026
• Supplement Report FDA Received Date: 08/05/2026
• 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: Other
• Patient Age: 53 YR
• Patient Sex: Unknown