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	Seroma (2069); Deformity/ Disfigurement (2360); Impaired Healing (2378); Breast Mass (2439); Swollen Lymph Nodes/Glands (4432); Breast Discomfort/Pain (4504); Nodule (4551); Swelling/ Edema (4577)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Hologic has received correspondence arising from litigation.The litigation alleges that a patient of undisclosed age, on (b)(6) 2018, underwent a right breast lumpectomy with biozorb placement and a simultaneous left breast lift.Shortly thereafter, the patient was diagnosed with ductal carcinoma in her right breast, and on (b)(6) 2018, she underwent re-excision with biozorb replacement.Following the surgeries, the patient developed a painful, long-term seroma in her right breast, along with persistent pain and tenderness at the implant site, nodule formation, and lymph node swelling that continued for years.Patient required needle drainage and was told she was experiencing "delayed healing." patient was later informed that hologic had extended the expected resorption timeline for biozorb - potentially up to two years, well beyond what she had originally been told.Patient has since suffered years of chronic pain, lymph node swelling, and an inability to wear a bra or swimsuit for any meaningful length of time without significant discomfort, requiring ongoing licensed massage therapy and lymph drainage at her own expense.In (b)(6) 2026, the patient observed new, deeper dimpling and disfigurement at the implant site.On (b)(6) 2026, having researched the device, patient learned for the first time that biozorb was subject to an fda class i recall.On (b)(6) 2026, an mri revealed a non-mass enhancement.A medical professional noted that the biozorb "somewhat limits evaluation of this mass." patient was subsequently diagnosed with invasive breast cancer and, on (b)(6) 2026, underwent a right mastectomy.No other relevant information was provided.
Additional Manufacturer Narrative
A device history record (dhr) review was not conducted because no lot number or udi were communicated.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: 50161479
• Report Number: 1222780-2026-00475
• Device Sequence Number: 10572177
• Product Code: NEU
• UDI-Device Identifier: 15420045513983
• UDI-Public: 15420045513983
• 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: 2018
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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
• Device Lot Number: Unknown
• 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: 08/03/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/29/2026
• 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