MySpine 7.0555Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040716888), received between Apr 30, 2019 and Apr 30, 2019 — 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2019Positioning Failure

  PROBLEMS WITH THE SETTING OF THE GUIDES L5 AND S1. THE SURGEON PUT THE L5 GUIDE ON THE VERTEBRA AND PREPARED THE HOLE. HE CHECKED IT ON X-RAY AND IT LOOKED GOOD, BUT WHEN HE HAS TO INSERT THE SCREWS, THE LEFT SCREW LOOKED VERY MEDIAL (NOT HOW HE PLANNED IT). HE TOOK THE SCREW OUT AND USED THE TIP FEELER TO CHECK IF HE IS OUTSIDE THE PEDICLE, BUT HE WASN´T. HE TRIED TO GET A BETTER ANGLE WHILE INSERTING THE SCREW FREEHAND. THE SCREW FOLLOWED THE PREVIOUS DIRECTION AND THE SURGEON DECIDED TO ACCEPT THE RESULT AND FINISHED THE SURGERY. AFTER CHECKING THE POST-OPERATION CT-SCAN THE SURGEON DECIDED TO DO A REVISION ON (B)(6) 2019, AFTER ONE MONTH FROM THE PRIMARY, BECAUSE THE SCREW WAS IN THE JOINT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8564994 ↗