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, but has not received further data, despite repeated attempts.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 complaints have been received for any of these lots.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; information concerning the event is being collected.

Manufacturer Narrative

Abyrx has received preliminary information concerning possible adverse tissue response from a physician, but has not received further data, despite repeated attempts.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 complaints have been received for any of these lots.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; 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 ; 9143572600
• MDR Report Key: 15596219
• MDR Text Key: 301656623
• Report Number: 3005972619-2022-00001
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• 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

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: OS-MON-1001
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Prefer Not To Disclose