MySpine 7.0724Recalls & reported problems
Medacta International SA · MySpine-MC drill guide L04 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630040717533), received between Feb 14, 2020 and Oct 11, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Insert” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Insert1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 11, 2023Positioning Failure; Positioning Failure
THE DRILL GUIDES DIDN'T FIT CORRECTLY ON THE L4/L5 PATIENT VERTEBRAS. THE GUIDES WERE USED DURING A NON MEDACTA PRODUCTS REVISION SURGERY, AFTER COMPETITOR PEDICLE SCREW REMOVAL AND BONE VERTEBRA DOCKS FOR GUIDES PREPARATION. THERE WAS A 30-MINUTE DELAY ON A 4-HOURS SURGERY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. A COMPETITOR NAVIGATION SYSTEM WAS USED TO COMPLETE THE SURGERY AND THE DELAY WAS DUE TO THE NAVIGATION SYSTEM SET UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17911814 ↗InjuryFeb 14, 2020Difficult to Insert
THE SURGEON WAS NOT ABLE TO SET THE MYSPINE MC GUIDE CORRECTLY AT L4- L5. THE SURGEON FINISHED THE SURGERY WITHOUT USING THE MYSPINE MC GUIDE. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 1 HOUR. TOTAL SURGERY TIME ABOUT 200 MINS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9710937 ↗
Other Pedicle Screw Placement Guide devices
- MySpine 7.0726Medacta International SA · Pedicle Screw Placement Guide3 reports
- MySpine 7.0725Medacta International SA · Pedicle Screw Placement Guide3 reports
- MySpine 7.0704Medacta 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
- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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