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

Model Number	F0221
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Breast Discomfort/Pain (4504)
Date of Event	10/11/2018
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) 2018, after a lumpectomy, after 1 week post-op, the patient reported significant pain in the area.The patient had a thin frame and small breasts.On reevaluation on (b)(6) 2018, the patient was seen by the physician and continued to report pain that had to take pain medication and that was disrupting her sleep, thus the patient requested the physician to remove the biozorb.The biozorb was removed on (b)(6) 2018, without complications.

• 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: 21674916
• Report Number: 1222780-2025-01115
• Device Sequence Number: 8209965
• Product Code: NEU
• UDI-Device Identifier: 15420045514027
• UDI-Public: (01)15420045514027(17)200430(241)F0221(10)H2-171108
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K152070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• 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
• Device Expiration Date: 04/30/2020
• Device Model Number: F0221
• Device Catalogue Number: F0221
• Device Lot Number: H2-171108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2017
• 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: 71 YR
• Patient Sex: Female