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

Model Number MONTAGE 5CC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/16/2020

Event Type  Injury  

Manufacturer Narrative

Upon receipt of lot number and patient information for the three cases, abyrx performed a thorough review of the associated batch records and the risk management file of the device.No discrepancies were noted in any of the lots.Additionally, abyrx reviewed usage for the surgeon and determined that multiple units were used from the same lots without incident.No additional complaints or adverse events were reported for any of the lots.No information indicates that the product malfunctioned or is out of specification.All patients are reported to be doing well with no additional complications requiring intervention.

Event Description

A physician communicated that a series of 3 patients had experienced unanticipated inflammation of the surgical site following use of montage in surgical procedures.These three patients required revision surgery to address swelling/fluid accumulation at the surgical site.Patients are reported as doing well with no further intervention required.

• Brand Name: MONTAGE SETTABLE RESORBABLE HEMOSTATIC BONE PUTTY
• Type of Device: MONTAGE SETTABLE RESORBABLE HEMOSTATIC BONE PUTTY
• Manufacturer (Section D): ABYRX, INC; 1 bridge st; suite 121; irvington, ny
• Manufacturer (Section G): ABYRX, INC; 1 bridge st; suite 121; irvington, ny
• Manufacturer Contact: aniq darr ; 1 bridge st; suite 121; irvington, ny ; 3572600216
• MDR Report Key: 10463696
• MDR Text Key: 205112286
• Report Number: 3005972619-2020-00001
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/17/2020

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 Model Number: MONTAGE 5CC
• Device Catalogue Number: OS-MON-1001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR