BIOZORB
Report
- Report Number
- 1222780-2023-00290
- Event Type
- Injury
- Date Received
- September 5, 2023
- Date of Event
- September 21, 2020
- Report Date
- April 15, 2025
- Manufacturer
- HOLOGIC, INC
- Product Code
- NEU
- UDI-DI
- 15420045513990
- PMA / PMN Number
- K143484
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT/SERIAL NUMBER. THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS. WE ARE CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED. 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.
THE PATIENT IS A 58-YEAR-OLD WOMAN, 175 LBS, AND BMI OF 28.34, WITH A SIGNIFICANT FAMILY HISTORY OF BREAST CANCER ALTHOUGH BRCA NEGATIVE AND NON-SIGNIFICANT PAST MEDICAL HISTORY SELF-IDENTIFIED A RIGHT BREAST MASS LOWER OUTER QUADRANT (LOQ) FOLLOWED BY MAMMOGRAM CONFIRMATION OF A SUSPICIOUS MASS FOLLOWED BY CORE BIOPSY CONFIRMING GRADE 3 INVASIVE DUCTAL CARCINOMA WITH DCIS, GRADE 3, TRIPLE NEGATIVE. MASS WAS 1.8 X 1.2 X 1.9CM ON MRI. THE PATIENT UNDERWENT NEOADJUVANT CHEMOTHERAPY OF DD AC-T. TAXOL RX #4/12 WAS HELD 1 WEEK DUE TO NEUTROPENIA. THE PATIENT HAD MULTIPLE CHEMOTHERAPY RELATED SIDE EFFECTS INCLUDING IRRITATED EYES, RAPID HR ITCHING, CHEST RASH SWOLLEN FEET, BLURRED VISION, AND HEADACHE AND WEIGHT LOSS. FULL TREATMENT WAS COMPLETED ON (B)(6) 2020 "WITH A GOOD RESPONSE". THE PATIENT UNDERWENT A PORT REMOVAL AND RIGHT BREAST LOQ NEEDLE LOCATED LUMPECTOMY WITH LYMPHATIC MAPPING AND SENTINEL LYMPH NODE DISSECTION (SLND), INSERTION OF A 2 X 3 CM BIOZORB AND PARTIAL BREAST RECONSTRUCTION WITH ADJACENT TISSUE TRANSFER (20 SQ CM) ON (B)(6) 2020. THERE ARE NO SURGICAL FOLLOW-UP RECORDS. THE PATIENT UNDERWENT RADIATION THERAPY (XRT), COMPLETED ON (B)(6) 2020. NOTES FROM MEDICAL ONCOLOGY TELEHEALTH VISIT ON (B)(6) 2021 REFLECT "DOING WELL, STILL HAS SOME MILD FATIGUE. TOLERATED XRT WELL. OCCASIONAL DIZZINESS." NOTES FROM DECEMBER 10TH 2021 WELLNESS CLINIC REFLECT "DENSITY" AT THE LUMPECTOMY SITE WITH SKIN CHANGES HOWEVER "BREAST PAIN NO" IS NOTED. ON (B)(6) 2022 A WELLNESS CHECK NOTED "SOME BREAST PAIN" IN A CHECKED BOX ON A FORM AND DENSITY LEFT LOQ BUT THERE IS NO FURTHER DESCRIPTION. ON FEBRUARY 8TH 2023 (2.5 YRS POST IMPLANT) THE MEDICAL ONCOLOGY VISIT NOTES REFLECT: "PAIN/CRAMPING TO BACK/BREAST RATED 1/10. IN THE LAST AVAILABLE CLINIC NOTE ON (B)(6) 2023 BREAST PAIN IS CIRCLED HOWEVER THERE IS NO NOTE OR REFERENCE TO THIS OTHERWISE. HER FINAL AVAILABLE MAMMOGRAM ON (B)(6) 2023 AND MRI ON DECEMBER 6TH 2023 WERE BOTH NEGATIVE FOR MALIGNANCY. LOT NUMBER PROVIDE WAS UNABLE TO BE TRACED.
CORRECT AFFECTED ITEM IS F0203.
IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB IN 2020. PATIENT IS REPORTING THAT SHE HAS SIGNIFICANT PAIN AND DISFIGUREMENT AND THAT SHE HAS HAD TO UNDERGO EXTRA SCANS DUE TO THE COMPLICATIONS. NO OTHER INFORMATION IS 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, 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.
CORRECTION TO: MWR-(B)(4). DATE OF REPORT ADDED.
IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB IN (B)(6) 2020. PATIENT IS REPORTING THAT SHE HAS SIGNIFICANT PAIN AND DISFIGUREMENT AND THAT SHE HAS HAD TO UNDERGO EXTRA SCANS DUE TO THE COMPLICATIONS. NO OTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1560136 | BIOZORB | MARKER, RADIOGRAPHIC, IMPLANTABLE | NEU | HOLOGIC, INC | F0203 | 15420045513990 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Unknown | Other |