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OSSDSIGN Cranial PSI XLRecalls & reported problems

Ossdsign AB · 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) · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07350086550115), received between Dec 19, 2018 and Dec 19, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 19, 2018Fracture; Fracture

    IT WAS REPORTED THAT THE PATIENT SPECIFIC IMPLANT ARRIVED AT THE OR WITH A FIXATION ARM BROKEN OFF. THE FIXATION ARM WAS CONTAINED WITHIN ITS PROTECTIVE SILICON SLEEVE AND THE DOUBLE STERILE PACKAGING REMAINED INTACT. SURGEON DECIDED TO USE THE IMPLANT AND PROCEEDED TO TRIM AWAY THE PIECE OF THE REMAINING FIXATION ARM. DURING THE TRIMMING A SMALL FRACTURE WAS INTRODUCED ON AN ADJACENT CERAMIC TILE DUE TO THE APPLIED FORCE. THE FIT OF THE IMPLANT WAS DEEMED AS GOOD AND THE REMAINING 5 FIXATION ARMS WERE USED TO FIXATE THE IMPLANT TO THE CRANIUM. OTHERWISE THE SURGERY WAS UNEVENTFUL AND NO COMPLICATIONS HAVE BEEN REPORTED SO FAR IN REGARD TO PATIENT OUTCOME.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8179301 ↗

Other Plate, Cranioplasty, Preformed, Non-Alterable devices

All Plate, Cranioplasty, Preformed, Non-Alterable devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.