MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-04-12 for MONTAGE SETTABLE, RESORBABLE HEMOSTATIC BONE PUTTY 900-ORT OS-MON-1001 manufactured by Abyrx Inc.
[72593135]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005972619-2017-00001 |
| MDR Report Key | 6486872 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-04-12 |
| Date of Report | 2017-04-12 |
| Date of Event | 2017-02-10 |
| Date Mfgr Received | 2017-03-09 |
| Device Manufacturer Date | 2016-08-30 |
| Date Added to Maude | 2017-04-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. ANIQ DARR |
| Manufacturer Street | 1 BRIDGE STREET SUITE 121 |
| Manufacturer City | IRVINGTON NY 10533 |
| Manufacturer Country | US |
| Manufacturer Postal | 10533 |
| Manufacturer Phone | 9143572600 |
| Manufacturer G1 | ABYRX INC |
| Manufacturer Street | 1 BRIDGE STREET SUITE 121 |
| Manufacturer City | IRVINGTON NY 10533 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 10533 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONTAGE SETTABLE, RESORBABLE HEMOSTATIC BONE PUTTY |
| Generic Name | CALCIUM PHOSPHATE BONE HEMOSTASIS MATERIAL |
| Product Code | MTJ |
| Date Received | 2017-04-12 |
| Model Number | 900-ORT |
| Catalog Number | OS-MON-1001 |
| Lot Number | 10267 |
| Device Expiration Date | 2017-08-30 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABYRX INC |
| Manufacturer Address | 1 BRIDGE STREET SUITE 121 IRVINGTON NY 10533 US 10533 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-12 |