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

Catalog Number OS-MON-1001

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 06/04/2022

Event Type  Injury  

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 Description

Abyrx has received preliminary information concerning possible adverse event from sales agent.Additional information concerning the event is being collected.

Event Description

Abyrx has received preliminary information concerning possible adverse event from sales agent.Additional information concerning the event is being collected.

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
• Type of Device: 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
• MDR Text Key: 301657106
• Report Number: 3005972619-2022-00003
• Device Sequence Number: 1
• Product Code: MTJ
• UDI-Device Identifier: 00850391007122
• UDI-Public: 0100850391007122172311301010789
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 05/19/2022
• Supplement Dates FDA Received: 03/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: AMNIOTIC MEMBRANE; AMNIOTIC MEMBRANE; COLLAGEN; COLLAGEN
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Prefer Not To Disclose