Valence Robotic Navigation System 525-423Recalls & reported problems
Alphatec Spine, Inc. · Valence Control Unit · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190376610566), received between Mar 3, 2025 and Aug 22, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Malposition of Device2
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Dural Tear1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2025Malposition of Device; Malposition of Device
A PATIENT UNDERWENT AN OPEN SPINAL PROCEDURE AT LEVELS L4-S1 ON (B)(6) 2025. THE SCREWS WERE THEN SUCCESSFULLY REPLACED UNDER FLUROSCOPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22873329 ↗MalfunctionMay 23, 2025Malposition of Device; Malposition of Device
DURING A SPINAL PROCEDURE IT WAS REPORTED THAT THE RIGHT L4 SCREW WAS NOT PLACED ACCORDING TO THE PLAN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22078352 ↗InjuryMar 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
DURING A SPINAL PROCEDURE UTILIZING THE ROBOTIC NAVIGATION SYSTEM, THE SURGEON INITIALLY USED A NON-NAVIGATED HIGH-SPEED BUR, TAP, AND SCREWDRIVER TO PLACE THE FIRST TWO SCREWS. HOWEVER, WHEN ATTEMPTING TO PLACE THE THIRD SCREW, THE SURGEON ENCOUNTERED DIFFICULTY ADVANCING THE TAP DUE TO SCLEROTIC BONE AFTER CREATING A PILOT HOLE WITH THE NON-NAVIGATED HIGH-SPEED BUR. AS A RESULT, THE SURGEON SWITCHED TO A LOW SPEED NAVIGATED DRILL TO CANNULATE THE PEDICLE AND PLACED THE SCREW. FOR SCREWS FOUR THROUGH SIX, THE SURGEON CONTINUED USING THE LOW SPEED NAVIGATED DRILL, FOLLOWED IMMEDIATELY BY SCREW PLACEMENT. DURING BONY DECOMPRESSION, THE SURGEON OBSERVED A MEDIAL BREACH OF SCREWS #3 AND #4, WITH ONE OF THE BREACHES CAUSING A DURAL TEAR. THE SURGEON SUCCESSFULLY REPAIRED THE TEAR AND REPLACED THE AFFECTED SCREWS WITHOUT ANY FURTHER COMPLICATIONS.
Patient problems: Dural Tear
MAUDE report 21508600 ↗
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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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