VSP Cranial Cranial Positioning GuideRecalls & reported problems
3d Systems, Inc. · A physical template / guide that conforms to patients’ anatomy (Bony) to allow manipulation of free floating bony anatomy. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816847021425), received between Sep 27, 2022 and Sep 27, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Positioning Failure” (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
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 27, 2022Positioning Failure; Positioning Failure
DURING A CRANIAL VAULT PROCEDURE UTILIZING VIRTUAL SURGICAL PLANNING, A SURGICAL CRANIAL POSITIONING GUIDE APPEARED TO BE TOO SMALL TO FIT THE BONE SEGMENTS CREATED UTILIZING A CORRESPONDING SURGICAL MARKING GUIDE. THE SURGEON OPTED TO NOT UTILIZE THE CRANIAL POSITIONING GUIDE AND AS A RESULT, REPORTED A 2 HOUR DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15491849 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.