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

Model Number	F0202
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Cellulitis (1768); Erythema (1840); Fever (1858); Inflammation (1932); Breast Discomfort/Pain (4504); Swelling/ Edema (4577); Abnormal scarring (4896)
Date of Event	05/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.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.
Event or Problem Description
Hologic has received correspondence arising from litigation.The litigation alleges a patient received a biozorb breast marker on (b)(6) 2016, with a margin re-excision on (b)(6), 2016.It is alleged that in late 2018, the patient developed "right breast pain and palpable lumps in the upper outer quadrant," and "imaging at that time showed post-surgical changes and was interpreted as benign." it is further alleged that in (b)(6) 2023, the patient experienced an "inflammatory event involving the right breast," and "presented with significant pain, erythema, edema, and fever up to 102 degrees, and was admitted for right breast cellulitis." additionally, it is reported that "ct imaging demonstrated postsurgical changes, skin thickening, and a fluid collection consistent with abscess formation." the patient is reported to have "required hospitalization, intravenous antibiotics, and prolonged outpatient treatment." further, the litigation alleges that the patient's "breast symptoms did not fully resolve, and she continued to report right breast pain and scarring on subsequent imaging studies.By early 2025, screening mammography again required additional imaging due to abnormalities and scarred fibroglandular tissue." it is reported that the patient "subsequently underwent a right simple mastectomy with sentinel lymph node biopsy on march 25, 2025.Following mastectomy, "[the patient]" continued to experience right chest wall pain, described as shooting and neuropathic in nature, requiring treatment with gabapentin." the litigation alleges that the biozorb was removed on april 7, 2025.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: 24605823
• Report Number: 1222780-2026-00120
• Device Sequence Number: 10343561
• Product Code: NEU
• 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: 2016
• 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): 09/30/2026

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: F0202
• Device Catalogue Number: F0202
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 09/30/2026
• 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 Sex: Unknown