Home › Neuramedica Inc. › DuraFuse Dural Clip

DuraFuse Dural Clip

Neuramedica Inc. · Model DC-501 · UDI-DI 00860007130403

FZP Prescription

510(k) clearances

42,394

Adverse events (126 deaths)

Recalls

107

Facilities

Description

NeuraMedica Dural Clips are bioabsorbable surgical clips designed to aid in closure of the dura mater in neurosurgical and orthopedic spine procedures. NeuraMedica Dural Clips are 3mm wide by 4.6mm long. They are applied using a reusable stainless steel applier. The NeuraMedica Applier is a separately-supplied reusable instrument.

Recalls

Date	Firm	Reason
2023-04-28	TELEFLEX LLC	Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for the affected product is missing a key feature that restricts the application of th
2021-04-16	Aesculap Implant Systems LLC	Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
2021-04-16	Aesculap Implant Systems LLC	Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
2020-09-17	Genicon, Inc.	Device malfunction causing the applier to jam, and clip loading failures.
2019-11-07	Ethicon Endo-Surgery Inc	A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility.
2019-10-04	Teleflex Medical	Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming
2019-10-04	Teleflex Medical	Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming
2018-04-02	AESDEX	Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components.
2018-04-02	AESDEX	Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components.
2018-01-22	Aesculap Implant Systems LLC	Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. A publication from 2017 recommended Aesculap DS Clips for k

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.