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	02/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the implantation of order: (b)(4) at (b)(6) hospital, one of eight tiles demonstrated partial delamination of the top (i.E.Smooth) layer of collagen.The delamination exposed the vicryl sutures.
Additional Manufacturer Narrative
No adverse event reported.

• 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: 16534897
• Report Number: 3014663932-2023-00006
• Device Sequence Number: 6388768
• Product Code: KXK
• UDI-Device Identifier: 60860000064509
• UDI-Public: (01)60860000064509(11)230213(17)230220(10)00001218
• 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-08
• Device Lot Number: 00001218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 03/13/2023
• 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
• Patient Sex: Unknown