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OSSDSIGN Cranial PSI

Ossdsign AB · Model L · UDI-DI 07350086550108

GXN Prescription

510(k) clearances

827

Adverse events (2 deaths)

Recalls

Facilities

Description

OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient’s unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids (510(k) no. K161090)

Recalls

Date	Firm	Reason
2018-08-22	Zimmer Biomet, Inc.	Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
2018-08-22	Zimmer Biomet, Inc.	Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
2018-08-22	Zimmer Biomet, Inc.	Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
2018-08-22	Zimmer Biomet, Inc.	Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
2018-08-22	Zimmer Biomet, Inc.	Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
2018-08-22	Zimmer Biomet, Inc.	Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
2017-06-10	Kelyniam Global, Inc.	Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the
2017-06-10	Kelyniam Global, Inc.	Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the
2017-06-10	Kelyniam Global, Inc.	Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the
2017-06-10	Kelyniam Global, Inc.	Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the

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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.