My Spine Low Profile Placement Guides 7.0524Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030878060), received between Jun 7, 2018 and Jun 7, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Malposition of Device” (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.

• InjuryJun 7, 2018Malposition of Device

  DURING A CASE THAT WAS SUPPOSED TO BE AN L4-L5 FUSION, THE L4 MYSPINE GUIDE BRIDGE SEATED TOO LOW. THE SURGEON HAD TO TAKE DOWN THE INTERSPINOUS LIGAMENT BETWEEN L3 AND L4 IN ORDER FOR THE GUIDE TO SEAT PROPERLY. ADDITIONALLY THE L5 GUIDE WAS VERY LARGE AND THE SURGEON DID NOT WANT TO HAVE TO EXPOSE SO MUCH. INTRAOPERATIVELY THE SURGEON MADE THE DECISION TO PERFORM A DECOMPRESSION. THE SURGEON MENTIONED THAT HIS DECISION TO PERFORM A DECOMPRESSION WAS NOT A RESULT OF THE MYSPINE GUIDES BUT BASED ON THE PATIENT'S ANATOMY.

  Patient problems: No Code Available

  MAUDE report 7578031 ↗