SPINEMASK 6002-390-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 37613252731437), received between Mar 12, 2020 and Oct 13, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Imprecision” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2020Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A SPINAL PROCEDURE AT THE USER FACILITY THE DEVICE WAS INACCURATE WHEN MEASURING BOTH THE MEDIAL AND LATERAL PATIENT LANDMARKS LEADING TO INACCURATE SCREW PLACEMENT. THE PLACEMENT WAS CORRECTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10672909 ↗
• MalfunctionMar 12, 2020Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE DEVICE WAS INACCURATE DURING A PROCEDURE. DURING A POSTERIOR FUSION PERCUTANEOUS CASE THE DEVICE WAS FOUND TO HAVE BEEN INACCURATE FOR A SCREW AND TAP PLACEMENT AND USE OF THE DEVICE WAS ABORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9823813 ↗