MySpine Unilateral Guide 7.1027Recalls & reported problems
Medacta International SA · MySpine Unilateral left guide S01 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630345786586), received between Aug 22, 2024 and Aug 22, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fitting Problem” (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.
Reports received per month
Most reported problems
Device problems
- Fitting Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2024Fitting Problem; Fitting Problem
THE TRAJECTORY OBTAINED USING MYSPINE UNILATERAL GUIDES AT S01 AND L5 WAS INCORRECT. HE BEGAN AT S1 AND ACCORDING TO HIM HE DID A THOROUGH SOFT TISSUE DISSECTION AND WAS SATISFIED THAT THE IN SITU FIT WAS JUST AS SOLID AS THE FIT ON THE VERTEBRAL MODEL. HE INTRODUCED THE DRILL AND TOOK A FLUORO SHOT, INDICATING THE TRAJECTORY WAS INCORRECT. HE SPENT ALMOST 30-40 MINUTES TRYING TO GET THE GUIDE POSITIONED CORRECTLY BUT WAS CONVINCED THAT THE GUIDE WAS PROBABLY PRINTED INCORRECTLY. HE THEN MOVED ONTO THE LEFT L5 GUIDE. AFTER A THOROUGH SOFT TISSUE DISSECTION AND AN INDICATED OSTEOTOMY, HE DOCKED THE GUIDE AND AFTER INTRODUCING THE DRILL AND TAKING A FLOURO SHOT WE SAW THAT THE TRAJECTORY WAS INCORRECT. HE CONTINUED TO DO MORE DISSECTION AND TOOK A SECOND SHOT AFTER DOCKING THE GUIDE BUT THE TRAJECTORY WAS STILL OFF. HE DECIDED AT THAT POINT TO FREEHAND THE SCREWS. THE SURGEON DECIDED TO PLACE THE SCREWS FREEHAND. THE ISSUE CAUSED 30-40 MINUTES DELAY; TOTAL SURGERY TIME 281 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20031372 ↗
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- My Spine Low Profile Placement Guides 7.0412Medacta International SA · Pedicle screw placement guide1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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