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DuraGen XS™ Dural Regeneration Matrix
Integra Lifesciences Corporation · Model DXM1033 · UDI-DI 10381780070979
GXQ
Prescription
1
510(k) clearances
1,404
Adverse events (36 deaths)
23
Recalls
41
Facilities
Description
DuraGenXS Matrix Dural Regeneration Matrix is an absorbable implant for repair of dural defects. DuraGenXS Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGenXS Matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
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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Get your free API keyRead the docsData 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.