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

Model Number OS-MON-1001

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868)

Event Type  Injury  

Manufacturer Narrative

10.Langerhans cell histiocytosis (lch) is an inflammatory myeloid neoplasia caused by mutations in several genes in the mapkinase pathway.Lch is a disorder in which excess langerhans cells (immune cells) build up in the body and form tumors called granulomas.As noted in the case report, "the etiology of this adverse outcome was likely multifactorial.Past research has suggested that the use of any foreign material in patients with lch may stimulate cellular proliferation, as histiocytes are already predisposed to activation".Abyrx has performed a review of the risk management file for montage, which notes the possible risk of chronic inflammatory response.In this procedure, the device was not used in accordance with the instructions for use and the underlying condition may have contributed to the outcome.No device lot number was provided; abyrx performed a review of device history records and no irregularities or nonconformities were noted, including all aspects of sterilization.No additional similar complaints have been received concerning foreign body reaction.Abyrx will revise the complaint file if any additional information is received.

Event Description

The case involved a 13-year-old boy with previously diagnosed langerhans cell histiocytosis.He underwent resection of a skull lesion and cranioplasty using montage.Two years postoperatively, the patient developed a symptomatic foreign body reaction at the graft site.This reaction prompted the removal and its replacement with a split-thickness autologous bone graft.

• Brand Name: MONTAGE SETTABLE RESORBABLE HEMOSTATIC BONE PUTTY
• Type of Device: Wax, bone
• Manufacturer (Section D): ABYRX, INC; 700 fairfield ave; suite 1; stamford CT 06902
• Manufacturer Contact: alyssa mcdermott ; 700 fairfield ave; suite 1; stamford, CT 06902 ; 9143572600
• MDR Report Key: 18190448
• MDR Text Key: 328779715
• Report Number: 3005972619-2023-00001
• 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: Literature
• Reporter Occupation: Dentist
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OS-MON-1001
• Device Catalogue Number: OS-MON-1001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2023
• 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: 13 YR
• Patient Sex: Male