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

Model Number	F0203
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Bacterial Infection (1735); Hematoma (1884); Inflammation (1932); Seroma (2069); Breast Mass (2439); Breast Discomfort/Pain (4504)
Date of Event	02/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot number.The device was released meeting all qa specifications.
Event or Problem Description
Hologic has received correspondence arising from litigation.The litigation alleges that a 59-year-old patient was submitted to a surgical intervention of left breast partial mastectomy with biozorb implantation on (b)(6) 2017.Mammogram from (b)(6) 2018 showed seroma and hematoma on lumpectomy site.On (b)(6) 2018 the patient presented with increase pain in left breast and an ultrasound guided aspiration of left breast abscess was performed.The abscess recurred again in (b)(6) 2019.On (b)(6) 2019 the patient presented with a left breast chronic abscess treated with multiple courses of antibiotics and aspiration but the patient was submitted to abscess drainage and surgical cleaning of the entire inflamed mass so the biozorb was explanted at the same time.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 s.

• 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: 25141148
• Report Number: 1222780-2026-00218
• Device Sequence Number: 9316479
• Product Code: NEU
• UDI-Device Identifier: 00851766006016
• UDI-Public: (01)00851766006016(17)180731(241)F0203(10)B1-160212
• 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: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2026

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: F0203
• Device Catalogue Number: F0203
• Device Lot Number: B1160212
• 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: 04/13/2026
• Supplement Date Received by Manufacturer: 09/04/2026; 09/04/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 09/14/2026; 09/14/2026
• 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: 59 YR
• Patient Sex: Unknown