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

Model Number	F0203
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	08/16/2018
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.The device involved in this event was returned for evaluation purposes.Review of returned product did not reveal a conclusive root cause for the deficiency.Fracture occurred at gate feature but cause of fracture could not be determined.The gate feature is exposed to the greatest stresses during the manufacturing process, but final inspection includes a visual inspection to confirm that the spacer material has not been damaged at the gate during the forming process.No additional cracks or fractures were observed elsewhere on the part.It is unclear whether the device fractured in place or during cutting of sutures and removal of the device from the tissue cavity.A review of the device itself and all appropriate documentation could not confirm a deficiency.The biozorb device is expected to lose integrity as part of the normal degradation process.However, because the device is sutured in place, the clips are still held at the periphery of the cavity in a 3-dimensional array even if the spacer fractures as a result of degradation/resorption (see image of device attached).Therefore, the fracture did not represent a failure of the device to meet design criteria or specifications and functional integrity of the device was intact prior to removal.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Event or Problem Description
It was reported that on (b)(6) 2018, a patient received a biozorb device after lumpectomy.On (b)(6) 2018, the biozorb was removed due to a mastectomy due to positive margins and the device was found to be in 2 pieces.The product was returned for investigation.The patient was reported to have chemotherapy on unknown dates and additionally an infection positive for staph aureus on an unknown date.No other information could be obtained.

• 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 ; coyol free zone building b24; alajuela; alajuela, 20102- CRI ; CS 20102 CRI
• MDR Report Key: 21674917
• Report Number: 1222780-2025-01112
• Device Sequence Number: 15506494
• Product Code: NEU
• UDI-Device Identifier: 15420045513990
• UDI-Public: 15420045513990
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2025

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: F0203
• Device Catalogue Number: F0203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female