MAUDE Adverse Event Report: ABYRX INC MONTAGE SETTABLE, RESORBABLE HEMOSTATIC BONE PUTTY; CALCIUM PHOSPHATE BONE HEMOSTASIS MATERIAL

Model Number 900-ORT

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

Patient Problem Unspecified Infection (1930)

Event Date 02/10/2017

Event Type  Injury  

Event Description

A physician communicated that an infection had occurred at a site where montage was used.The procedure involved an incision made inside of the mouth for an orthognathic procedure on the maxilla.Montage was used on the maxilla to control bleeding in conjunction with the implantation of hardware (plate).Approximately four weeks after the surgery date the implant site had become infected, which required a surgical procedure to remove all potentially infected implant materials, treat the infection, and replace the plate.The patient was said to be doing well following this procedure.The surgeon did not remove all excess montage as instructed in the ifu and used the product in a contaminated area.The product ifu includes a precaution against placement in contaminated or infected areas.A review of the batch records for the lot did not uncover any irregularities.No other customer complaints have been reported for use of product from this lot.No information supports a product malfunction or an out of specification product.If more information becomes available it will be provided.

• Brand Name: MONTAGE SETTABLE, RESORBABLE HEMOSTATIC BONE PUTTY
• Type of Device: CALCIUM PHOSPHATE BONE HEMOSTASIS MATERIAL
• Manufacturer (Section D): ABYRX INC; 1 bridge street; suite 121; irvington NY 10533
• Manufacturer (Section G): ABYRX INC; 1 bridge street; suite 121; irvington NY 10533
• Manufacturer Contact: aniq darr ; 1 bridge street; suite 121; irvington, NY 10533 ; 9143572600
• MDR Report Key: 6486872
• MDR Text Key: 72593135
• Report Number: 3005972619-2017-00001
• 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: Other
• Type of Report: Initial
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/30/2017
• Device Model Number: 900-ORT
• Device Catalogue Number: OS-MON-1001
• Device Lot Number: 10267
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/09/2017
• Initial Date FDA Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2016
• 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: 30 YR