MAUDE Adverse Event Report: Theragenics Corporation I125 AnchorSeed/TSL in FlatPack; I-SEED (AgX100); SOURCE, BRACHYTHERAPY, RADIONUCLIDE

Model Number	T616136, T616137, T616138
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Malfunction

• Brand Name: I125 AnchorSeed/TSL in FlatPack
• Common Device Name: I-SEED (AgX100); SOURCE, BRACHYTHERAPY, RADIONUCLIDE
• Manufacturer (Section D): Theragenics Corporation; 5203 bristol industrial way; buford GA 30518
• Manufacturer (Section G): Theragenics Corporation; 5203 bristol industrial way; buford GA 30518
• Manufacturer Contact: riley bennett ; 5203 bristol industrial way; buford, GA 30518 ; +1(770)831-4230
• MDR Report Key: 50681003
• Report Number: 1037598-2026-01130
• Device Sequence Number: 13365072
• Product Code: KXK
• UDI-Device Identifier: 00813787021331
• UDI-Public: 00813787021331
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K103319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2026

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 Expiration Date: 08/13/2026
• Device Model Number: T616136, T616137, T616138
• Device Catalogue Number: TG77315iF
• Device Lot Number: X26-0729
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (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