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	Breast Mass (2439); Breast Discomfort/Pain (4504); Limb Pain (4836)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Hologic has received correspondence arising from litigation.The litigation alleges that a 55 year old patient was implanted on (b)(6) 2020 with a biozorb marker following a surgical procedure for a left breast lumpectomy.The patient underwent the prescribed radiation and endocrine therapy.On (b)(6) 2023 the patient presented at a medical consultation with a painful persistent palpable mass in the left breast.The pain increased with movement and when pressed along the implant site incision line.The patient indicated the symptoms were persistent during the last 3 years.The md discussed with the patient the possibility to schedule an explanation surgery and the patient agreed.On (b)(6) 2023 the patient underwent a surgical procedure for left breast mass excision, together with the biozorb implant which was included in the breast mass.No other relevant information was provided.
Additional Manufacturer Narrative
Hologic has received correspondence arising from litigation.The litigation alleges that a 55 year old patient was implanted on (b)(6) 2020 with a biozorb marker following a surgical procedure for a left breast lumpectomy.The patient underwent the prescribed radiation and endocrine therapy.On (b)(6) 2023 the patient presented at a medical consultation with a painful persistent palpable mass in the left breast.The pain increased with movement and when pressed along the implant site incision line.The patient indicated the symptoms were persistent during the last 3 years.The md discussed with the patient the possibility to schedule an explantation surgery and the patient agreed.On (b)(6) 2023 the patient underwent a surgical procedure for left breast mass excision together with the biozorb implant which was included in the breast mass.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.

• 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: 50037276
• Report Number: 1222780-2026-00459
• Device Sequence Number: 10421116
• 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: 2020
• Device Explanted Year: 2023
• 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: 07/21/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 07/27/2026
• 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 Age: 55 YR
• Patient Sex: Unknown