Home › Integra Lifesciences Corporation › Integra® Bovine Pericardium Dural Graft

Integra® Bovine Pericardium Dural Graft

Integra Lifesciences Corporation · Model BP10812 · UDI-DI 10381780074243

GXQ Prescription

510(k) clearances

1,404

Adverse events (36 deaths)

Recalls

Facilities

Description

Integra® Bovine Pericardium Dural Graft is a natural, resorbable, collagenous device for use in the repair of dura mater. The device is derived from bovine pericardium and is manufactured using a multistep proprietary process which gently cleans and dehydrates the tissue. The device is terminally sterilized by gamma irradiation. The device must be sutured in place.

Recalls

Date	Firm	Reason
2024-11-22	Cook Biotech, Inc.	Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
2024-09-26	Integra LifeSciences Corp.	Out of specification endotoxin levels.
2023-06-13	Medtronic Neurosurgery	Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and finished goods endotoxin testing, which may present clinically with signs
2021-12-13	Collagen Matrix, Inc.	Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
2021-12-13	Collagen Matrix, Inc.	Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
2015-12-08	Synthes (USA) Products LLC	It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon
2015-12-08	Synthes (USA) Products LLC	It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon
2015-12-08	Synthes (USA) Products LLC	It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon
2015-12-08	Synthes (USA) Products LLC	It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon
2015-12-08	Synthes (USA) Products LLC	It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.