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

Model Number	F0202
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Scar Tissue (2060); Seroma (2069); Sleep Dysfunction (2517); Breast Discomfort/Pain (4504); Swelling/ Edema (4577)
Date of Event	03/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022 biozorb procedure was performed, and the patient reported suffered from irritation, swelling, reddening of the skin, pain, itching, discomfort, and difficulty sleeping.The patient reported having the biozorb device removed on or around (b)(6) 2023.No additional information available.
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.
Additional Manufacturer Narrative
After additional information review, it was reported that the patient is a 59-year-old woman, with a body max index of 32 and 194 pounds.The patient presented in (b)(6) 2022, approximately 6 months post implant, with breast pain, swelling and erythema.She was diagnosed with cellulitis and treated initially as an outpatient on oral antibiotics.After several days without resolution and with continued fever, the patient was hospitalized from (b)(6), 2022, for left breast infection.The patient was placed on iv antibiotics and underwent ultrasound guided drainage of the breast abscess.Culture of the fluid revealed moderate staphylococcus lugdunensis.Decision was made not to remove the biozorb.She was discharged home with improvement of symptoms on oral antibiotic therapy.Breast mri on (b)(6) 2022, revealed on the left, " post-surgical findings from a previous lumpectomy with radiation seen in the lower inner quadrant of the left breast.A rim enhancing fluid collection is present measuring 5.9 x 2.3x 1.7 cm.Suspect seroma, but infected seroma not able to be fully excluded--suggest clinical correlation.Skin thickening noted.The right breast was unchanged from previous study.There is a note to the plaintiff¿s attorney which indicates an infection in (b)(6) 2022; there are no other relevant medical records available.Besides the email to the attorney, there are no additional available medical records from (b)(6) 2022 to (b)(6) 2023.Visit with surgeon on (b)(6) 2023, approximately 1.5yrs post implant, notes patient has ¿tenderness in the region of the lumpectomy site and is considering removal of the biozorb marker." examination of the left breast on this visit noted ¿scar in the lower aspect of the left breast with tenderness and what appears to be perhaps fixation of tissue to the chest wall.¿ on (b)(6) 2023, the patient underwent device explant.The patient had a palpable lesion in the lower aspect of the left breast at the site of the previous lumpectomy.The skin was marked over the lesion and then the skin was anesthetized using marcaine.A 3 cm incision was made through the previous scar and extended through the subcutaneous tissue.A flap was then created over the palpable lesion, and then the mass was grasped and excised using the electrocautery and maintaining hemostasis throughout the procedure.At the center of the mass was a biozorb marker which was excised in its entirety with the specimen and was noted to be intact without any apparent resorption of the collagen.A small amount of peripheral breast tissue was obtained with the specimen.Hemostasis was meticulously assured.The specimen was not oriented for margins as it was obviously benign reactive tissue.On (b)(6) 2023, the patient presented to the emergency department with a pulse of 220 associated with jaw pain and mild elevations of troponin and was hospitalized from (b)(6) 2023.She had a mildly abnormal stress and a left heart catheterization with mild nonobstructive disease with sluggish flow in the lad that improved with nitroglycerin.Imdur and aspirin were added to her regimen.The patient stated that before the addition of imdur she was having constant left sided chest pain.She had a cardiology visit on (b)(6) 2023 and was reported to have a history of supraventricular tachycardia, nstemi/ mild nonobstructive coronary artery disease and dyslipidemia.Office visit note indicates ¿abnormal mammogram" on the left breast approximately (b)(6)2024, no other details available.The patient noted to have osteopenia and left fibular fracture.An investigation was completed: it was reported that on (b)(6) 2022 a biozorb procedure was performed, and the patient reported suffered from irritation, swelling, reddening of the skin, pain, itching, discomfort, and difficulty sleeping.The patient reported having the biozorb device removed on or around (b)(6) 2023.No additional information available.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), major additional intervention (additional surgery/device explantation/calcifications), hypersensitivity/allergic reaction (redness/erythema and/or itching sensation), 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 device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.
Additional Manufacturer Narrative
It was reported that on (b)(6) 2022 a biozorb procedure was performed, and the patient reported suffered from irritation, swelling, reddening of the skin, pain, itching, discomfort, and difficulty sleeping.The patient reported having the biozorb device removed on or around (b)(6) 2023.No additional information available.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), major additional intervention (additional surgery/device explantation/calcifications), hypersensitivity/allergic reaction (redness/erythema and/or itching sensation), 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 was performed for a1-200810.There were no deviations to note.

• 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: 17881197
• Report Number: 1222780-2023-00366
• Device Sequence Number: 7389931
• Product Code: NEU
• UDI-Device Identifier: 00851766006092
• UDI-Public: (01)00851766006092(17)230131(241)F0202(10)A1-200810
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 04/04/2025

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 Expiration Date: 01/31/2023
• Device Model Number: F0202
• Device Catalogue Number: F0202
• Device Lot Number: A1-200810
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 01/13/2025; 03/31/2025
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 02/11/2025; 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2020
• 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: Required Intervention; Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 88 KG