MySpine 7.0726Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040717571), received between Dec 12, 2018 and Sep 27, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2024Osseointegration Problem; Positioning Problem; Osseointegration Problem; Positioning Problem

  SPINAL FIXATION WAS PERFORMED AT L4-S1 WITH MYSPINE MC GUIDES. THE SURGEON FELT THAT THE GUIDE DID NOT FIT THE VERTEBRAL BODY AT L4-S1. THE SURGEON USED THE GUIDES ANYWAYS, EXCEPT FOR THE RIGHT SIDE OF L5, WHERE HE INSERTED THE PEDICLE SCREW (5.5 X 30MM) BY FREEHAND. AFTER DECOMPRESSION, THE PEDICLE SCREW LOOSEN, SO THE RIGHT SIDE OF L5 WAS SKIPPED. THE SURGERY WAS COMPLETED WITH 30 MIN DELAY (TOT TIME 5 HOURS). THE SURGEON SUSPECTS THAT THE GUIDES ARE FOR THE WRONG PATIENT.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320898 ↗
• MalfunctionNov 20, 2019Adverse Event Without Identified Device or Use Problem

  DURING THE PRIMARY SPINE SURGERY, WHILE THE SURGEON WAS DRILLING THE S1 GUIDE HOLES, THE SURGEON OBSERVED THAT THE S01 GUIDE WAS TOO LARGE FOR THE INCISION MADE. THE SURGEON HAD TO MAKE HIS INCISION LARGER IN ORDER TO USE THE S01 GUIDE. THERE WAS A 35-MINUTE DELAY IN THE CASE AND NO ADDITIONAL ANAESTHESIA WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY. CASE CODE: (B)(4).

  Patient problems: No Code Available

  MAUDE report 9346918 ↗
• MalfunctionDec 12, 2018Inadequacy of Device Shape and/or Size

  THE SURGEON WAS NOT ABLE TO DRILL SAFETY BECAUSE THE SLEEVE PART LENGTH OF MYSPINE S01 DRILL BASED GUIDE WAS TOO SHORT IN COMPARISON WITH OTHERS. MOREOVER IT WAS NOT ABLE TO SET ON THE SPINAL BONE STABLE. THE SURGEON DRILLED ONLY THE ENTRY POINT UNDER THE IMAGING AND PROCEEDED FREEHAND DRILLING CAUSING A CRITICAL DELAY IN THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8155012 ↗