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

Model Number	F0231
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Unspecified Infection (1930); Itching Sensation (1943); Burning Sensation (2146); Breast Discomfort/Pain (4504)
Date of Event	10/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device identifier: (b)(4).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.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.H3: 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 and a definitive root cause for the reported event could not be determined.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 on (b)(6) 2020, a biozorb procedure was performed and the patient reported suffering from pain, itching, tenderness, and a burning sensation at and around the site of the biozorb device.Also, the patient reported suffering from adverse skin reactions and suffering from infection.No additional information available.
Additional Manufacturer Narrative
After additional information review, it was reported that the patient is a 63-year-old female (no additional information available) who had a diagnosis of malignant neoplasm of the right breast upper outer quadrant.She underwent right breast lumpectomy, sentinel lymph node biopsy and biozorb implant on (b)(6) 2020, without complications.The operative note reflects: "a biozorb low profile 2 x 3 x 1 was sutured into the lumpectomy cavity with #3-0 pds.The purpose of the biozorb device is to provide a slowly dissolving matrix for the ingrowth of tissue to prevent a cosmetic defect from volume loss of the breast after lumpectomy; as well as to accurately locate the true margins for the radiation oncologist.This is the single medical record available for review.
Additional Manufacturer Narrative
An investigation was conducted: brief description: it was reported that on (b)(6) 2020, a biozorb procedure was performed and the patient reported suffering from pain, itching, tenderness, and a burning sensation at and around the site of the biozorb device.Also, the patient reported suffering from adverse skin reactions and suffering from infection.As a result of the pain and complications of the biozorb device, the patient fears the possibility of another tumor every day, causing significant emotional distress.No additional information available.Investigation methods and 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, based on clinical symptoms and hazardous situations for this complaint are: - pain, serious (pain, sleep dysfunction, device palpability, failure to resorb).- hypersensitivity/allergic reaction, serious (redness/erythema, itching sensation).- infection, serious (infection).- foreign body reaction, serious (adverse reaction due to device materials).Cause/root cause: the described issue was investigated through a root cause analysis conducted under capa.The initial purpose of this capa was to evaluate the biozorb product for a root cause linking the product design to the reported complaint issues.The results of the root cause assessment did not find any direct link between the device and the reported complaint issues.Consequently, the implementation activities from capa were considered no longer applicable since hologic has ceased selling the biozorb product with no intention of returning it to market.In addition, capa is currently evaluating the biozorb product¿s entire dhf and is actively under remediation.Furthermore, a voluntary recall for the biozorb product was initiated on october 24, 2024.Conclusion: the reported issue could not be confirmed as no sample was returned for evaluation.The risk trending analysis does not increase the risk zone index.The potential root cause analysis was assessed under capa.Capa is currently evaluating the biozorb product¿s entire dhf and is actively under remediation.The risks associated with this event are further detailed and evaluated against the product and its hazard analysis within the health risk assessment biozorb, complaint evaluation.Future events will be monitored and trended.Complaint confirmed: no.Device history record (dhr) review: not performed.No lot number was provided; therefore, no dhr could be located or reviewed.

• Brand Name: BIOZORB
• Common Device Name: MARKER, RADRIOGRAPHIC, 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: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose 20102
• MDR Report Key: 18815075
• Report Number: 1222780-2024-00087
• Device Sequence Number: 12829867
• Product Code: NEU
• UDI-Device Identifier: 15420045514034
• UDI-Public: 15420045514034
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K143484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2026

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: F0231
• Device Catalogue Number: F0231
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2023
• Supplement Date Received by Manufacturer: 02/06/2025; 04/24/2026
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 03/06/2025; 04/30/2026
• 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: 63 YR
• Patient Sex: Female