MAUDE Adverse Event Report: ABYRX, INC MONTAGE SETTABLE RESORBABLE HEMOSTATIC BONE PUTTY

Catalog Number	OS-MON-1001
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Abyrx has received preliminary information concerning possible adverse tissue response from a physician.Initial dos (b)(6) 2022 for mtp fusion utilizing montage in conjunction with two types of third-party amniotic tissue products and two types of third-party collagen-based products.It is unclear if the products were used in accordance with the instructions for use.Abyrx performed a review of device history records for this lot, and no irregularities or nonconformities were noted, including all aspects of sterilization.No additional complaints have been received for this lot.Abyrx will revise the complaint file if any additional information is received.
Event or Problem Description
Abyrx has received preliminary information concerning possible adverse event from sales agent.Additional information concerning the event is being collected.
Event or Problem Description
Abyrx has received preliminary information concerning possible adverse event from sales agent.Additional information concerning the event is being collected.
Additional Manufacturer Narrative
Abyrx has received preliminary information concerning possible adverse tissue response from a physician.Initial dos 2022/01/12 for mtp fusion utilizing montage in conjunction with two types of third-party amniotic tissue products and two types of third-party collagen-based products.It is unclear if the products were used in accordance with the instructions for use.Abyrx performed a review of device history records for this lot, and no irregularities or nonconformities were noted, including all aspects of sterilization.No additional complaints have been received for this lot.Abyrx will revise the complaint file if any additional information is received.

• Brand Name: MONTAGE SETTABLE RESORBABLE HEMOSTATIC BONE PUTTY
• Common Device Name: RESORBABLE HEMOSTATIC BONE PUTTY
• Manufacturer (Section D): ABYRX, INC; 1 bridge st; suite 121; irvington NY 10533
• Manufacturer (Section G): ABYRX, INC; 1 bridge st; suite 121; irvington NY 10533
• Manufacturer Contact: alyssa mcdermott ; 1 bridge st; suite 121; irvington, NY 10533
• MDR Report Key: 15596286
• Report Number: 3005972619-2022-00003
• Device Sequence Number: 2215445
• Product Code: MTJ
• UDI-Device Identifier: 00850391007122
• UDI-Public: 0100850391007122172311301010789
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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: 11/30/2023
• Device Catalogue Number: OS-MON-1001
• Device Lot Number: 10789
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 03/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMNIOTIC MEMBRANE; AMNIOTIC MEMBRANE; COLLAGEN; COLLAGEN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Prefer Not To Disclose