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

Model Number	F0404
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a routine re-excision procedure, the surgeon chose to remove the device that was "flat" and replaced it with a new device.No patient complications were reported.The device was returned for investigation, and it was determined that the device had deformed in-situ, there was no sign of device fracture and that the clips were in proper location on device.The biozorb is expected to lose integrity as part of the normal degradation process and has flexibility to accommodate movement and contractures of the surrounding site.Because the device is sutured in placed the clips are still held in a 3-dimenstional array even if the spacer configuration changes as a result of degradation/resorption or tissue movement, therefore this was not considered a failure of the device to meet the design criteria.
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.Lot 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.The device involved in this event was returned for evaluation purposes.The evaluation of the device in question confirms the customer's observation that the device was deformed in-situ.There was no sign of device fracture, and all clips were intact in proper location on the device.The nature of the device materials is such that the tissue environment can mold the device over time during degradation.However, the intended use of the biozorb is not to mimic a tissue cavity, but to mark a site of clinical interest in soft tissue.The biozorb device is expected to lose integrity as part of the normal degradation process and has flexibility to accommodate movement and contractures of the surrounding tissue.Because the device is sutured in place, the clips are still held in a 3-dimensional array even if the spacer configuration changes as a result of degradation/resorption or tissue movement.Therefore, this does not represent a failure of the device to meet design criteria or specifications, and functional integrity of the device was intact prior to removal.

• 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; alajuela, alajuela 20102- CRI ; CS 20102 CRI
• MDR Report Key: 21157839
• Report Number: 1222780-2025-01005
• Device Sequence Number: 8433646
• Product Code: NEU
• UDI-Device Identifier: 15420045514058
• UDI-Public: 15420045514058
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: F0404
• Device Catalogue Number: F0404
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2016
• Initial Report FDA Received Date: 01/15/2025
• 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; Hospitalization
• Patient Sex: Female