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 Codes	Necrosis (1971); Seroma (2069); Breast Discomfort/Pain (4504)
Date of Event	10/04/2018
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.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) 2018 a patient underwent a right partial mastectomy with a biozorb implantation.The patient had a prior diagnosis of invasive lobular carcinoma on her right breast.Patient has reported experiencing pain, pulling, swelling, seroma, fat necrosis and a lump of scar issue and the implantation site of the biozorb.The patient underwent an excisional biopsy of an enlarging area in her right breast adjacent to her surgical scar, the biozorb was removed and tissue around was found to be atypical lobular hyperplasia.No other information is available.
Additional Manufacturer Narrative
After additional medical review it was a 56-year-old female patient, weight 177 lbs.And bmi of 29.5.Received a biozorb implant (2x2x1 secured with 3.0 monocryl) on (b)(6) 2018, during a lumpectomy on her right breast with sentinel lymph node biopsy.Pathology result revealed a stage 1a grade 2 t1cn0m0 er/pr positive, and her-2 negative, oncotype score 13 low risk for recurrence and 4/4 lymph nodes were negative and margins were clean.Patient post op course was negative, and she underwent uncomplicated radiotherapy of whole breast and boost from (b)(6) 2018, up until (b)(6) 2018.On a follow up consult patient was referred to physical therapy for pain of upper breast and axilla assumed to be lymphedema and muscle tightness attributed to the scar tissue.Patient started on letrazole and had uneventful follow up except for the onset of diabetes type2, hyperlipidemia, atrial fibrillation, osteoarthritis and osteopenia.Patient had negative follow ups until 3.3 years after the lumpectomy when she developed tenderness and a firm 1cm palpable mass superior to the lumpectomy scar with a negative diagnostic mammogram and ultrasound on (b)(6) 2022.Concerns about recurrence led the surgeon to re-excise the lumpectomy site and on (b)(6) 2022, the site was re-excised with explant of remainder of biozorb device.The pathology results revealed: 4 surgical clips, friable solid white debris and 1x0.9x0.5 cm fibrous tissue and atypical lobular hyperplasia.In a follow up mri on (b)(6) 2022, the patient had a 3.8 cm seroma palpable by the surgeon with occasional swelling and pain that resolved without treatment.Patient had a negative exam on (b)(6) 2023.Patient had a history of abnormal but inconclusive screening mammogram on her right breast in (b)(6) 2017 and a positive screen for 7.5 mm mass in right upper inner quadrant on (b)(6) 2018.Patient underwent right breast core needle biopsy with marker placement in (b)(6) 2018 which came out positive for invasive lobular carcinoma grade 2 with lcis.Diabetes type2, hyperlipidemia, atrial fibrillation, osteoarthritis and osteopenia.Family history revealed 2 first cousins diagnosed with cancer 1 year prior to event.Patient history revealed: type 2 diabetes, hyperlipidemia, atrial fibrillation, osteo arthritis, gerd, colon polyps benign, hyperlipidemia, osteoporosis, lichen sclerosis, depression, past history smoking, oral contraceptives for 30 years, hormone replacement therapy for 6 years.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.
Additional Manufacturer Narrative
It was reported that on (b)(6), 2018, a patient underwent a right partial mastectomy with a biozorb implantation.The patient had a prior diagnosis of invasive lobular carcinoma on her right breast.Patient has reported experiencing pain, pulling, swelling, seroma, fat necrosis and a lump of scar tissue as well as a brown scar and indention at site of the biozorb.The patient underwent an excisional biopsy of an enlarging area in her right breast adjacent to her surgical scar, the biozorb was removed and tissue around was found to be atypical lobular hyperplasia.Patient relieves their breast cancer diagnosis and fear it has returned, 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: major pain (pain/discomfort/device palpability/sleep disfunction/failure to resorb), minor inflammation (inflammation/swelling/lymphedema/limited mobility), scar tissue (scar tissue and/or delayed wound healing), seroma, major additional intervention (additional surgery/device explantation /calcifications), major tissue damage (necrosis), physical asymmetry (deformity).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 regards 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, 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 ; 562 parkway; coyol free zone building b24; san jose 20102
• MDR Report Key: 17691435
• Report Number: 1222780-2023-00319
• Device Sequence Number: 6531718
• Product Code: NEU
• UDI-Device Identifier: 15420045514027
• UDI-Public: 15420045514027
• Combination Product (Y/N): N
• Initial Reporter State: SC
• PMA/510(K) Number: K152070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• 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): 03/12/2025

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: F0221
• Device Catalogue Number: F0221
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2022
• Supplement Date Received by Manufacturer: Not provided; 02/12/2025
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 11/01/2024; 03/12/2025
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 80 KG