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

Model Number	F0304
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.
Event or Problem Description
It was reported that the patient had a lumpectomy and biozorb placement on (b)(6) 2015.Pathology determined the margins were positive and a re-excision was done on (b)(6) 2015.During the re-excision the physician removed the biozorb device so the tissue could be re-excised and noted that the marker was broken at the midpoint of the coil.No additional medical or surgical intervention was reported.The device was returned for investigation and a conclusive root cause for the deficiency could not be found.The biozorb is expected to lose integrity as part of the normal degradation process.However, because the device is sutured in placed the clips are still held at the periphery of the cavity in a 3-dimensional array even if spacer fractures as a result of the degradation/resorption.

• 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 ; coyol free zone building b24; alajuela; alajuela, 20102- CRI
• MDR Report Key: 21137992
• Report Number: 1222780-2025-01002
• Device Sequence Number: 6824891
• Product Code: NEU
• UDI-Device Identifier: 15420045514010
• UDI-Public: 15420045514010
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K143484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2025

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
• Device Expiration Date: 07/01/2017
• Device Model Number: F0304
• Device Catalogue Number: F0304
• Device Lot Number: D1-150218
• 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: 08/19/2015
• Initial Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2015
• 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 Sex: Female