My Spine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides 7.0727Recalls & reported problems
Medacta International SA · MySpine S02 left guide · Class 2
Data updated Oct 18, 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 07630971255784), received between May 4, 2021 and May 4, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning 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 18, 2026.
Most reported problems
Device problems
- Positioning 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.
MalfunctionMay 4, 2021Positioning Problem
THE POSITION OF THE TUBE, WHICH INDICATES THE SCREW TRAJECTORY, WAS COMPLETELY DIFFERENT IN COMPARISON WITH THE PLANNING. THIS EVENT WAS DISCOVERED THE DAY BEFORE THE SURGERY AND THE SURGERY WAS POSTPONED BY A WEEK. THE EVENT WAS NOTICED USING THE K-WIRE WITH THE GUIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11770197 ↗
Other Pedicle Screw Placement Guide devices
- MySpine 7.0725Medacta International SA · Pedicle Screw Placement Guide3 reports
- MySpine 7.0726Medacta International SA · Pedicle Screw Placement Guide3 reports
- MySpine 7.0704Medacta International SA · Pedicle Screw Placement Guide2 reports
- MySpine 7.0724Medacta International SA · Pedicle Screw Placement Guide2 reports
- MySpine 7.0723Medacta International SA · Pedicle Screw Placement Guide2 reports
- My Spine Low Profile Placement Guides 7.0412Medacta International SA · Pedicle screw placement guide1 report
- My Spine Low Profile Placement Guides 7.0524Medacta International SA · Pedicle screw placement guide1 report
- MySpine Unilateral Guide 7.1027Medacta 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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