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); Breast Discomfort/Pain (4504)
Date of Event	12/08/2021
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.D4: lot and serial number of the device not provided by the complainant; 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.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) 2021 a biozorb was implanted to the patient and the patient reported suffering a hard, painful lump that had developed near the site of the biozorb device, which has not dissolved.No additional information available.
Additional Manufacturer Narrative
After additional medical review it was determined that 61 years old patient, 122 pounds, with pmh of 20 pack year smoker, alcohol, marijuana, and depression had an asymptomatic screening mammogram on (b)(6) 2020 reported as focal asymmetry in the left breast at 11:00, and on u/s a 1.0x1.2x0.9 spiculated mass was identified.The patient underwent left breast u/s guided core needle biopsy on (b)(6) 2020.The pathology report, however according to other medical records was reported as moderately differentiated invasive ductal carcinoma grade 2 er+, pr+, her2 negative ki67=10%.On (b)(6) 2021 breast mri revealed a second left breast mass at 10:00 measuring 0.9x0.5x0.4cm and an additional mass at 12:00 measuring 0.7x0.7x0.5cm.The patient started pre- operative adjuvant anastrazole therapy on (b)(6) 2021 with an "excellent clinical response" by mri on (b)(6) 2021.On (b)(6)2022 left breast diagnostic mammogram identified a persistent 07x0.5x0.6 mass.On (b)(6)2021 the patient underwent a "left breast savi scout localized partial mastectomy with re-excision of the superior margin (same surgery), sln, biopsyx3, adjacent tissue transfer or rearrangement greater than 20cm with placement of 1x2x3 cm biozorb." the patient had an uneventful surgical recovery and underwent whole breast and boost radiation treatments x 19 from (b)(6) 2022 with grade 1 skin redness and fatigue.The patient recovered fully from her surgery and xrt.She continued the anastrazole anti estrogen treatment without complaints.The medical record provides no further follow/up.During the patient¿s course of treatment and recovery there is no mention of biozorb related pain or tenderness.Although the patient requested information about the lot number of the biozorb implant on a visit on (b)(6) 2023 she remained asymptomatic at that time according to her medical records.Family medical history: niece aged 33 breast cancer (deceased); sister aged 56 breast cancer recent diagnosis.Patient medical history: 20 pack year smoking; alcohol use; marijuana use; ocpx15 years; squamous cell carcinoma of the nose and lt calf; rt partial knee replacement; osteopenia/osteoporosis; self reports depression treated with antidepressant.
Additional Manufacturer Narrative
It was reported that on (b)(6) 2021 a biozorb was implanted to the patient and the patient reported suffering a hard, painful lump that had developed near the site of the biozorb device, which has not dissolved.As a result of the pain and complications the patient fears the possibility of another tumor every day, causing significant emotional distress.No initial evaluation could be performed because there was no returned sample for this complaint.The sample was not returned for this complaint and there was limited patient-related information provided for this event; therefore, a thorough investigation was not able to be performed.Investigation into several of the harms reported in this complaint was performed from a clinical literature review, as well as an investigation into the design and risk of the biozorb product.The harms identified during this complaint are: pain, device palpable, failure to resorb reported.A review of clinical literature performed on lumpectomies and their associated complications was performed.A summary of this review concluded that, while lumpectomy is a well-established option for breast cancer treatment, it inherently carries risks of complications, most notably infections, seroma formation, chronic pain, and wound healing issues.The literature demonstrates variation in complication rates based on surgical technique, additional therapies (such as intraoperative radiation therapy (iort) or radiation), and individual patient factors, with infection rates ranging from 2% to 10% and seroma rates from 11% to 65%.Chronic pain, particularly neuropathic pain, affects nearly one-third of patients.(kwee et al.(2024)), migration can be influenced by several patient related factors which can influence the likelihood of migration after lumpectomy, such as breast density, biopsy location, and biopsy approach.Per a study by ashali jain et al.(2017), marker migration is a relatively common occurrence following stereotactic biopsies, happening in 13% of cases.Swelling is one of the expected events that could occur after surgery and/or radiation therapy regardless of the use of a biozorb device.Due to this, confirmation of the swelling during this event as a normal course of surgery vs being caused by the biozorb is not able to be done.Device explantation is based on the patient¿s physician¿s evaluation of their physical and health state and recommendation; therefore, an investigation into this intervention is not able to be performed for this complaint.Though complications are relatively common, most are manageable with appropriate postoperative care, making lumpectomy a viable option for many breast cancer patients when carefully monitored and followed up.An investigation was performed by subject matter experts (sme¿s) into several of the harms identified as being experienced by the patient related to design, risk management, and clinical factors.The results of these investigations and potential causes can be seen below; however, it is important to note that these results do not include medical input from a qualified medical professional: pain: there is a lack of migration requirements and testing to evaluate if the device can cause tissue damage due to migration.Verification of mechanical strength and simulated use is not adequate due to several opportunities related to sampling size and test methods.The crystalline proportion in the device is unknown.Crystallinity may be causing irritation and foreign body reaction considering the long period of absorption of the device.There is a lack of usability testing evaluating the user needs, so there is no assurance that the surgical methods being used for the users are adequate.There is a lack of adequate user needs to capture appropriate design inputs, and therefore there are opportunities in design outputs and v&v activities.Migration: there is a lack of migration requirements and testing to evaluate if the device can cause tissue damage due to migration.The crystalline proportion in the device is unknown.High crystallinity may be causing migration/erosion considering the long period of absorption of the device.Verification of mechanical strength and simulated use is not adequate due to several opportunities related to sampling size and test methods.There is a lack of usability testing evaluating the user needs, so there is no assurance that the surgical methods being used for the users are adequate.There is a lack of adequate user needs to capture appropriate design inputs.Based on the clinical literature review, the harms reported to be experienced by the patient in the complaint are common symptoms from surgery and lumpectomies; therefore, a confirmation of the biozorb causing the harms was not able to be done.However, based on the review of the top harms in regard to the biozorb design and risk documentation, the adverse events reported can be tracked back to a potential shared cause: lack of adequate user needs for the product.User needs define the framework for product development and lay the ground for the definition of design inputs, design outputs and later verification and validation activities.Other potential causes are related to inadequate test methods and/or the lack of evidence to support some specific product requirements.Conclusion: when comparing the safety outcomes of the biozorb marker with general lumpectomy complications, it becomes evident that some of the complications associated with biozorb may stem from the lumpectomy procedure itself.Both procedures share overlapping risks, although the biozorb device introduces additional considerations.However, it has been confirmed that the lack of defined user needs and inadequate test methods and testing evidence are potential root causes for the harms reported in this complaint.This cause will be further investigated and addressed in a capa.The risks associated with this complaint event are further described and evaluated against the product and its hazard analysis in the health risk assessment biozorb complaint analysis.Updates to the biozorb hazard analysis risk file will be monitored.Future events will be monitored and trended.Complaint confirmed: no.Device history record (dhr) review: a dhr review could not be performed because no lot information was provided.

• 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: 17686139
• Report Number: 1222780-2023-00299
• Device Sequence Number: 17712531
• Product Code: NEU
• UDI-Device Identifier: 15420045514034
• UDI-Public: 15420045514034
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K152070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 05/19/2025

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 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: 04/04/2023
• Supplement Date Received by Manufacturer: Not provided; 04/21/2025
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 11/14/2024; 05/19/2025
• 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: 61 YR
• Patient Sex: Unknown
• Patient Weight: 55 KG