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DURA-GUARD Dural Repair Patch

SYNOVIS LIFE TECHNOLOGIES, INC. · Model DG0608SN · UDI-DI 00085412531007

GXQ Prescription

510(k) clearances

1,397

Adverse events (36 deaths)

Recalls

Facilities

Description

DURA-GUARD Dural Repair Patch is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. DURA-GUARD Dural Repair Patch is chemically sterilized using ethanol and propylene oxide. DURA-GUARD Dural Repair Patch has been treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20 - 25 C. DURA-GUARD Dural Repair Patch is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.

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

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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.