MAUDE Adverse Event Report: FOCAL THERAPEUTICS BIOZORB; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number F0304

Device Problems Fracture (1260); Material Protrusion/Extrusion (2979)

Patient Problems Wound Dehiscence (1154); Necrosis (1971)

Event Date 09/02/2016

Event Type  malfunction  

Event Description

Surgery in early (b)(6): (r) needle localization segmental mastectomy with placement of a biozorb tissue marker.This was seen in surgical clinic by partner and registered nurse practitioner (rnp) for hematoma.Follow-up and monitoring occurred in surgical clinic six, nineteen, and twenty two days later.Dehiscence of breast wound with partial evacuation of hematoma prompting take-back to the operating room (or) twenty six days post-mastectomy.Delay of initiation of chemotherapy by 5 days for breast wound fistula overlying the biozorb.Notation of protrusion of a fractured prong of the biozorb device through the breast wound between cycle 3 and 4 of 4 cycles of chemotherapy.Last chemo treatment occurred in early (b)(6).The removal of the defective biozorb device and resection of the wound and fistula and resection of the fat necrosis in the segmentectomy bed, occurred at the end of (b)(6).(27 days delay to allow for improvement in the immunosuppression and poor wound healing associated with chemotherapy.).

• Brand Name: BIOZORB
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): FOCAL THERAPEUTICS; 1010 stewart dr.; sunnyvale CA 94085
• MDR Report Key: 6386915
• MDR Text Key: 69366858
• Report Number: 6386915
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: F0304
• Device Lot Number: DI-160203
• Other Device ID Number: 1861168
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR