MAUDE Adverse Event Report: GT MEDICAL TECHNOLOGIES GAMMATILE; RADIONUCLIDE BRACHYTHERAPY SEEDS

Model Number	GT-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	12/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient was originally diagnosed in (b)(6) 2022 with a right temporal gbm.The tumor was resected and the patient received adjuvant radiation therapy of 60gy in 30 fractions between (b)(6), 2022 and (b)(6), 2022 along with chemotherapy.On (b)(6), 2022 a recurrent tumor was resected in the previous radiated field and the patient was treated with gammatile therapy.Radiation necrosis was identified and starting on (b)(6), 2022 the patient required medical treatment to preclude permanent impairment.Due to the previous radiation treatment and this being a re-radiation, it is not knwon whether gammatile casued or contributed to the radiation necrosis that was experienced.As of (b)(6) 2023, the patient was doing well.
Event or Problem Description
Patient experienced radiation necrosis approximately 2 months post implant which required medical intervention.

• Brand Name: GAMMATILE
• Common Device Name: RADIONUCLIDE BRACHYTHERAPY SEEDS
• Manufacturer (Section D): GT MEDICAL TECHNOLOGIES; 350 hills street; suite 108; richland WA 99354
• Manufacturer (Section G): GT MEDICAL TECHNOLOGIES; 350 hills street; suite 108; richland WA 99354
• Manufacturer Contact: jessica newhard ; 1809 s holbrook lane; suite 107; tempe, AZ 85281 ; 4802768609
• MDR Report Key: 16624905
• Report Number: 3014663932-2023-00010
• Device Sequence Number: 12079505
• Product Code: KXK
• UDI-Device Identifier: 50860000064502
• UDI-Public: (01)50860000064502(11)221007(17)221014(10)00001035
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K190839
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2023

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: GT-001
• Device Catalogue Number: GT-05
• Device Lot Number: 00001035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2023
• Initial Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MAINTENANCE CHEMOTHERAPY; OPTUNE TTF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown