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

Model Number	GT-001
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to a phone conversation between the chief technology officer and the attending neurosurgeon (dr.(b)(6), dr.(b)(6) proceeded to implant each of the three tiles as he thought the strands were still anchored in the base piece and further secured those tiles with surgicel.He did not have concerns about the placement or adherence and confirmed that a scan on (b)(6) 2023 did not show anything of concern.No adverse event has been reported.
Event or Problem Description
During the implantation of order: (b)(4) at (b)(6) hospital, three of fourteen tiles demonstrated partial delamination of the top (i.E.Smooth) layer of collagen.

• 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: 16534896
• Report Number: 3014663932-2023-00005
• Device Sequence Number: 6388767
• Product Code: KXK
• UDI-Device Identifier: 60860000064509
• UDI-Public: (01)60860000064509(11)230208(17)230213(10)00001212
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: GT-001
• Device Catalogue Number: GT-14
• Device Lot Number: 00001212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2023
• 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
• Patient Sex: Unknown