NA 5450800310Recalls & reported problems
Stryker Corporation · Spetzler/Barracuda Tip, Universal · Class U
Data updated Oct 16, 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 07613252026709), received between Jul 21, 2021 and Jul 22, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Improper or Incorrect Procedure or Method1
Patient problems
- Nerve Damage1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25907788 ↗InjuryJul 21, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SURGEON USED AN INCORRECT STRYKER SONOPET PRODUCT. IT WAS ALSO REPORTED THAT THE PATIENTS FACIAL NERVE WAS MISTAKENLY CUT BY THE SURGEON. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Nerve Damage
MAUDE report 12206774 ↗
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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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