MySpine 7.0725Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040717557), received between Dec 10, 2019 and Apr 1, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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.

• InjuryApr 1, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  TLIF SURGERY WAS SUCCESSFULLY PERFORMED AT L5-S1 WITH MYSPINE MC GUIDE. A FEW DAYS LATER, CT SCAN REVEALED THAT UPPER-LEVEL L5 SCREW HAD PERFORATED THE CRANIAL INTERVERTEBRAL DISC. THE SURGEON POINTED OUT THAT THE LOWER PART OF THE GUIDE SLEEVE HAD BEEN SHORTENED AND THERE WAS AN EXCESSIVE SPACE BETWEEN THE GUIDE AND THE BONE MODEL.

  Patient problems: Perforation

  MAUDE report 21737328 ↗
• InjuryMay 28, 2020Appropriate Device Problem Term/Code Not Available

  DURING THE PRIMARY SPINE SURGERY, WHILE THE SURGEON WAS IMPLANTING THE LEFT SCREW AT L5, A LATERAL BREACH OF THE LEFT L5 VERTEBRAE OCCURRED. THERE WAS A 15-MINUTE DELAY AND THE SURGEON FREE-HANDED THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON FOLLOWED THE PROCEDURE AND DID NOT EXPERIENCE ANY ISSUES WITH ANY OF THE OTHER SCREWS IN THIS CASE OR HIS PREVIOUS CASE. THERE WAS NO BREACH UNTIL THE SURGEON FULLY IMPLANTED THE SCREW. NO FITTING ISSUE HAS BEEN REPORTED BETWEEN BONE MODEL/PATIENT'S BONE AND GUIDES.

  Patient problems: Bone Fracture(s)

  MAUDE report 10095418 ↗
• InjuryDec 10, 2019Material Protrusion/Extrusion

  REVISION SURGERY PERFORMED DUE TO BACK PAIN. THE TRAJECTORY OF THE PEDICLE SCREW IN L5 RIGHT WAS NOT CORRECT AND THE TIP PROTRUDED OUT OF THE PEDICLE, IT WAS REPOSITIONED THE SAME SCREW. CASE CODE: (B)(6).

  Patient problems: Pain

  MAUDE report 9443539 ↗