Vault C ACDF System 37-IN-0010Recalls & reported problems
Precision Spine, Inc. · Implant Insertion Handle · Class 1
Data updated Oct 16, 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 00840019916875), received between Nov 19, 2020 and Nov 19, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult or Delayed Separation” (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.
Most reported problems
Device problems
- Difficult or Delayed Separation1
- Physical Resistance/Sticking1
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.
InjuryNov 19, 2020Physical Resistance/Sticking; Difficult or Delayed Separation
DURING A PROCEDURE PERFORMED IN DUBAI ON AN UNKNOWN DATE, THE IMPLANT INSERTION HANDLE (B)(4) WAS GETTING STUCK ON THE CAGE INSIDE THE DISC SPACE AND DIFFICULT TO DETACH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO HARM TO THE PATIENT, BUT WITH A ONE (1) HOUR DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10868043 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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