MySpine 7.0723Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630040717519), received between May 25, 2023 and May 26, 2023 — classified as 1 injury, 1 malfunction.

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

Recent adverse event reports

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

• InjuryMay 26, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING THE PRIMARY SPINE SURGERY, THE MYSPINE GUIDES DID NOT FIT PROPERLY ON THE VERTEBRAE AFTER DISSECTION. THE SURGEON USED FLUOROSCOPY TO COMPLETE THE CASE. THERE WAS A 1 HOUR AND 30 MINUTE DELAY DUE TO GUIDES ISSUE AND ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE SURGERY WAS COMPLETED SUCCESSFULLY. TOTAL SURGERY TIME: 3.5 TO 4 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010038 ↗
• MalfunctionMay 25, 2023Positioning Failure; Positioning Failure

  DURING THE PRIMARY SPINE SURGERY, THE MYSPINE GUIDES DID NOT FIT PROPERLY ON THE VERTEBRAE AFTER DISSECTION. THE SURGEON USED A BRIDGE GUIDE AT L4 WAS ABLE TO USE THE MYSPINE GUIDES BUT HAD TO USE FLUOROSCOPY AT L5. THERE WAS A 1 HOUR AND 30 MINUTE DELAY DUE TO GUIDES ISSUE AND ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE SURGERY WAS COMPLETED SUCCESSFULLY. TOTAL SURGERY TIME: 3.5 TO 4 HOURS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17000836 ↗