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

Model Number	F0202
Health Effect - Clinical Codes	Pain (1994); Rash (2033); Discomfort (2330); Deformity/ Disfigurement (2360); Swelling/ Edema (4577)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
I received the biozorb while having a lumpectomy for malignant ductal carcinoma of the right breast.Shortly after surgery began having discomfort and was told over and over that the implant would dissolve.Fast forward to today (b)(6) 2026 i have swelling, pain, disfiguration as well as rash in the area.Recent mammogram reveals it is still completely intact.Scheduled for removal (b)(6) 2026.

• Brand Name: BIOZORB MARKER
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): HOLOGIC, INC.
• MDR Report Key: 24649215
• Report Number: MW5185452
• Device Sequence Number: 10207526
• Product Code: NEU
• UDI-Device Identifier: 00851766006009
• UDI-Public: (01)00851766006009(17)230228(241)F0202(10)A1-200915
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/12/2026

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?: Yes
• Device Expiration Date: 02/28/2023
• Device Model Number: F0202
• Device Lot Number: A1-200915
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2026
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN 81.; BENICAR 40MG.; COQ10.; KRILL OIL.; LUMIGAN EYE DROPS.; METOPROLOL.; PLAQUENIL.; REPATHA INJECTION.; VITAMIN D3 5000IU.
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention; Disability
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Race: White