MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-09-19 for BIODESIGN OTOLOGIC REPAIR GRAFT ENT-OTO-2.5X2.5 manufactured by Cook Biotech.
[120737498]
Date of event not provided by the complainant. Lot number not provided by the complainant. Product expire date unknown; lot number not provided. Implant date not provided by the complainant; reported as end of (b)(6) 2018. Concomitant medical products: grace medical notched titanium bucket handle; gelfoam. 510(k): k161000. Based on nci terminology, a granuloma is defined as an inflammatory reaction usually caused by infectious organisms, foreign bodies, or cholesterol deposits. It is characterized by the presence of epithelioid histiocytes and chronic inflammation. Https://ncit. Nci. Nih. Gov/ncitbrowser/pages/concept_details. Jsf? Dictionary=nci_thesaurus&version=18. 08d&code=c3064&ns=ncit&type=properties&key=586501374&b=1&n=0&vse=null a review of the ifu revealed that? Inflammation (initial application of surgical device materials may be associated with transient, mild, localized inflammation)? Was noted amongst the list of potential complications that? Are possible with the use of surgical device materials in otologic procedures.? The device is contraindicated for use in? Patients with known sensitivity to porcine material? As the device is derived from a porcine source. The root cause, of the granuloma, is inconclusive. A stapedectomy typically involves the removal of the stapes bone and a prosthesis is implanted in place of the stapes. In this patient, a grace medical notched titanium bucket handle was implanted to replace the stapes bone. Gelfoam was also used as a packing material. In the absence of the patient having any known sensitivity to porcine material, the biodesign device unlikely contributed to the granuloma. It is possible the patient had a response to other material used during the procedure.
Patient Sequence No: 1, Text Type: N, H10
[120737499]
Dr. (b)(6) performed a stapedectomy in a male patient in (b)(6) 2018. While elevating a flap, an incidental tear occurred. A biodesign otologic repair graft was utilized instead of harvesting an autologic graft. Gelfoam was placed under the ear drum. A grace medical notched titanium bucket handle was implanted to replace the stapes bone. One week post-surgery, the patient presented with severe ear pain and facial paralysis. The pain and paralysis were unresponsive to steroid treatment. At an unspecified time, the patient went back to surgery. A granuloma was found and excised. The granuloma was irritating a nerve. Post granuloma excision, the patient reportedly had no hearing loss and the facial paralysis was improving. Dr. (b)(6) reported only seeing one other instance of this occurrence in the last twelve years. Dr. (b)(6) was uncertain if the biodesign otologic repair graft was related to the occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1835959-2018-00010 |
| MDR Report Key | 7889714 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-09-19 |
| Date of Report | 2018-09-12 |
| Date Mfgr Received | 2018-09-07 |
| Date Added to Maude | 2018-09-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PERRY GUINN |
| Manufacturer Street | 1425 INNOVATION PLACE |
| Manufacturer City | WEST LAFAYETTE IN 47906 |
| Manufacturer Country | US |
| Manufacturer Postal | 47906 |
| Manufacturer Phone | 7654973355 |
| Manufacturer G1 | COOK BIOTECH INCORPORATED |
| Manufacturer Street | 1425 INNOVATION PLACE |
| Manufacturer City | WEST LAFAYETTE IN 47906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIODESIGN OTOLOGIC REPAIR GRAFT |
| Generic Name | OTOLOGIC REPAIR GRAFT |
| Product Code | KHJ |
| Date Received | 2018-09-19 |
| Catalog Number | ENT-OTO-2.5X2.5 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK BIOTECH |
| Manufacturer Address | 1425 INNOVATION PLACE WEST LAFAYETTE IN 47906 US 47906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-19 |