MAUDE Adverse Event Report: ABYRX, INC. PERMATAGE SETTABLE NONABSORBABLE HEMOSTATIC BONE PUTTY; Wax, bone

Model Number	OS-PER-1001
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Abyrx received communication regarding a use in canada of the permatage¿ settable, nonabsorbable bone putty in the treatment of a segmental defect of the distal tibia.The device was reportedly used to fill a segmental bone defect, without any supplemental fixation for stabilization of permatage in the procedure.Subsequently, the patient presented with dislodgement of the device from the application site.The use did not appear to be in accordance with the labeling for the device or appropriate medical practices.Abyrx confirmed with the sales representative that the device's instructions for use (ifu) had been provided to the operating surgeon prior to the procedure.The procedure itself was a revision of a previously failed total ankle implant.Further details regarding the primary procedure were not provided.The batch record for the device lot was reviewed in its entirety, including all documented steps of manufacturing, sterilization, sterile barrier integrity verification, and final release testing.All records were found to be complete and compliant with established procedures and specifications.There were no discrepancies, deviations, or concerns noted.The lot met all applicable quality and regulatory requirements and was accepted for release.
Additional Manufacturer Narrative
Abyrx received communication regarding a use in canada of the permatage¿ settable, nonabsorbable bone putty in the treatment of a segmental defect of the distal tibia.The device was reportedly used to fill a segmental bone defect, without any supplemental fixation for stabilization of permatage in the procedure.Subsequently, the patient presented with dislodgement of the device from the application site.The use did not appear to be in accordance with the labeling for the device or appropriate medical practices.Abyrx confirmed with the sales representative that the device's instructions for use (ifu) had been provided to the operating surgeon prior to the procedure.The procedure itself was a revision of a previously failed total ankle implant.Further details regarding the primary procedure were not provided.The batch record for the device lot was reviewed in its entirety, including all documented steps of manufacturing, sterilization, sterile barrier integrity verification, and final release testing.All records were found to be complete and compliant with established procedures and specifications.There were no discrepancies, deviations, or concerns noted.The lot met all applicable quality and regulatory requirements and was accepted for release.

• Brand Name: PERMATAGE SETTABLE NONABSORBABLE HEMOSTATIC BONE PUTTY
• Common Device Name: Wax, bone
• Manufacturer (Section D): ABYRX, INC.; 700 fairfield ave; suite 1; stamford CT 06902
• Manufacturer (Section G): ABYRX, INC; 700 fairfield ave; suite 1; stamford CT 06902
• Manufacturer Contact: alyssa mcdermott ; 700 fairfield ave; suite 1; stamford, CT 06902
• MDR Report Key: 22055699
• Report Number: 3005972619-2025-00001
• Device Sequence Number: 6950494
• Product Code: MTJ
• UDI-Device Identifier: 00850391007238
• UDI-Public: (01)00850391007238(17)250630(10)20197
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K202363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2025

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 Expiration Date: 06/30/2025
• Device Model Number: OS-PER-1001
• Device Catalogue Number: OS-PER-1001
• Device Lot Number: 20197
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Male