My Spine Low Profile Placement Guides 7.0412Recalls & reported problems
Medacta International SA · MySpine LP vertebra T12 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030877643), received between Nov 22, 2019 and Nov 22, 2019 — 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
Device problems
- Malposition of Device1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 22, 2019Malposition of Device; Malposition of Device
IN THE SAME CASE THE SURGEON WRONGLY INSERTED THE MYSPINE GUIDE AND THE SCREWS IN AN ALREADY INSTRUMENTED LEVEL. WRONG POSITION OF T12 GUIDE AND THEN 4 SCREWS WERE PLACED IN T11. THE WRONG SCREWS HAVE BEEN REMOVED AND REPLACED IN THE CORRECT LEVEL. THE NEXT LEVELS AND SCREWS HAVE BEEN CORRECTLY PLACED.
Patient problems: No Code Available
MAUDE report 9361143 ↗
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 7.0524Medacta International SA · Pedicle screw placement guide1 report
- My Spine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides 7.0727Medacta 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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