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  

Event Description

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

Manufacturer Narrative

Abyrx has received preliminary information concerning possible infection from a physician.Initial dos (b)(6) 2021 for charcot recon utilizing montage and a third-party amniotic membrane in conjunction with third-party hardware within the procedure.Patient presented for charcot revision requiring removal of hardware and remaining montage; surgeon noted active infection.It is unclear if the products were used in accordance with the instructions for use.No device lot number was provided despite multiple requests.Abyrx performed a review of distribution records to identify potential lots related to the issue.Subsequent to this, abyrx reviewed the device history records for all lots used by surgeon and no irregularities or nonconformities were noted, including all aspects of sterilization.No additional similar complaints have been received for any lots used by this physician.Abyrx will revise the complaint file if any additional information is received.

Manufacturer Narrative

Abyrx has received preliminary information concerning possible infection from a physician.Initial dos 2021/06/04 for charcot recon utilizing montage and a third-party amniotic membrane in conjunction with third-party hardware within the procedure.Patient presented for charcot revision requiring removal of hardware and remaining montage; surgeon noted active infection.It is unclear if the products were used in accordance with the instructions for use.No device lot number was provided despite multiple requests.Abyrx performed a review of distribution records to identify potential lots related to the issue.Subsequent to this, abyrx reviewed the device history records for all lots used by surgeon and no irregularities or nonconformities were noted, including all aspects of sterilization.No additional similar complaints have been received for any lots used by this physician.Abyrx will revise the complaint file if any additional information is received.

Event Description

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

• 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: 15596239
• MDR Text Key: 301656449
• Report Number: 3005972619-2022-00002
• Device Sequence Number: 1
• Product Code: MTJ
• 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 Catalogue Number: OS-MON-1001
• Device Lot Number: NOT PROVIDED
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: Not provided
• 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
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Prefer Not To Disclose