MySpine 7.0534Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040716628), received between Nov 9, 2018 and Nov 9, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Auto Stop” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionNov 9, 2018Failure to Auto Stop; Material Protrusion/Extrusion

  COMPLEX CASE (EXTREMELY SMALL PEDICLES) OF KYPHOTIC DEFORMITY. AT LEVEL T4 THE STARTING POINT OF RIGHT SCREW MOVED MORE VENTRALLY DUE TO THE TOPOGRAPHY OF THE VERTEBRA. WHEN THE SURGEON DRILLED HE FELT THAT THE DRILL WAS ADVANCING VERY DEEP INTO THE BONE, MORE THAN THE DRILL STOP SHOULD HAVE BEEN ALLOWED. WHEN HE MEASURED AFTERWARDS THE PROTRUSION OF THE DRILL OUT OF THE GUIDE HE HAD THE IMPRESSION THAT THIS DID NOT CORRESPOND TO THE 35 MM OF THE DRILL STOP SHOULD HAVE BEEN ALLOWED. ACCORDING TO THE SURGEONS THE GUIDE WAS CORRECTLY PLACED ON THE BONE. ACCORDING TO THE SURGEON, HE PUNCTURED THE THORACIC CAVITY WITH THE DRILL AND THE PATIENT NEEDED A DRAINAGE AFTERWARDS TO THE TREAT THE RESULTING PNEUMOTHORAX.

  Patient problems: Perforation

  MAUDE report 8054892 ↗