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

Model Number	F0331
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Hypersensitivity/Allergic reaction (1907); Breast Discomfort/Pain (4504)
Date of Event	06/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic is submitting this report in accordance with 21.Cfr part 803.The submission is based upon the currently available information.The submission of this report does not represent a confirmation of device malfunction involving the hologic products in the event described.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.The device involved in this event was not returned for evaluation purposes; therefore, visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
Event or Problem Description
It was reported that a patient received a biozorb device on (b)(6) 2019, after a lumpectomy.Multiple lesions were removed during surgery and axillary and sternum and neck were deemed positive.The patient was reported to receive chemotherapy (perjecta, caroplatin, herceptin, toxotere, and the patient had a complete response to chemo).The patient reported that she experienced pain due to the biozorb device.Additionally, the patient reported that she believes that it was affecting her white blood cell count, and that the chemotherapy was affecting her muscle mass.The patient also reported that she experienced allergic reactions and treatment for infection at the wound site.On (b)(6) 2020, the biozorb was removed with all metallic markers.

• 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: daniel guevara ; coyol free zone building b24; alajuela; alajuela, 20102- CRI ; CS 20102 CRI
• MDR Report Key: 21678278
• Report Number: 1222780-2025-01168
• Device Sequence Number: 18065632
• Product Code: NEU
• UDI-Device Identifier: 15420045514041
• UDI-Public: (01)15420045514041(17)200630(241)F0331(10)K2-180102
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2025

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 Expiration Date: 06/30/2020
• Device Model Number: F0331
• Device Catalogue Number: F0331
• Device Lot Number: K2-180102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2018
• 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; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female