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	Necrosis (1971); Seroma (2069); Breast Mass (2439); Breast Discomfort/Pain (4504)
Date of Event	03/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number of the device provided by the complainant is not a valid biozorb lot number; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.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.
Event or Problem Description
Hologic has received correspondence arising from litigation.The litigation alleges that a 59 year-old patient was implanted on (b)(6) 2018 with a biozorb marker following a surgical procedure for a left breast lumpectomy.On (b)(6 2025 patient presented with new tenderness and a chronic mass at the left breast level.She noted tenderness with palpation, otherwise does not hurt.A diagnostic mammogram and ultrasound performed on (b)(6) 2020 demonstrated chronic seroma on the left breast.A biopsy of the left breast mass on (b)(6) 2023 found fat necrosis and benign breast tissue.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.
Additional Manufacturer Narrative
An investigation was completed on sep 08, 2026.  it was reported that a 59 year-old patient was implanted on (b)(6)2018 with a biozorb marker following a surgical procedure for a left breast lumpectomy.On (b)(6) 2025 patient presented with new tenderness and a chronic mass at the left breast level.She noted tenderness with palpation, otherwise does not hurt.A diagnostic mammogram and ultrasound performed on (b)(6)2020 demonstrated chronic seroma on the left breast.A biopsy of the left breast mass on (b)(6)2023 found fat necrosis and benign breast tissue.No other relevant information was provided.Investigation findings: the sample was not returned to the post market quality laboratory for further investigation; therefore, the inspection according to the biozorb post market instructions was not able to be conducted for this complaint.Additionally, there was limited patient-related information provided for this event; consequently, a comprehensive investigation could not be conducted.The harms identified for this complaint were evaluated, based on clinical symptoms and hazardous situations per specific risk document.For additional details please refer to the complaint.Complaint confirmed: no .Probable cause: the described issue was investigated through a root cause analysis conducted under a specific capa document.The results of the root cause assessment did not find any direct causation link between the device and the reported complaint issues.Hologic has ceased selling the biozorb product with no intention of returning it to market.In addition, a capa is currently evaluating the biozorb product¿s dhf and is actively under remediation.Furthermore, a voluntary recall for the biozorb product was initiated on october 24, 2024.Device history record: a device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.Unique device identifier (udi): updated - please see d4.Lot number: updated - please see d4.Expiration date: updated - please see d4.Risk assessment: the risk assessment was performed for each symptom in accordance with the specific company risk documents.The harms identified in the biozorb hazard analysis were used to align with the reported clinical symptoms, as they represent known harms associated with biozorb device use.These harms were identified within the hazard analysis, master harms list or clinical judgement from clinical affairs representative.Updates to the biozorb hazard analysis risk file will be monitored.Future events will be monitored and trended.

• 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: 25255185
• Report Number: 1222780-2026-00317
• Device Sequence Number: 14807453
• Product Code: NEU
• UDI-Device Identifier: 00851766006085
• UDI-Public: (01)00851766006085(17)190430(241)F0331(10)K3-161102
• 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: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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 Expiration Date: 04/30/2019
• Device Model Number: F0331
• Device Catalogue Number: F0331
• Device Lot Number: K3-161102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 09/17/2026
• 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: 59 YR
• Patient Sex: Unknown