ACCULIF 400006Recalls & reported problems
Stryker Corporation · PL CAGE · Class 2 · Implant
All models of ACCULIF (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327066753), received between Feb 23, 2016 and Sep 26, 2016 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Collapse” (3 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 16, 2026.
Most reported problems
Device problems
- Collapse3
- Mechanical Problem3
- Device Dislodged or Dislocated1
- Noise, Audible1
- Pressure Problem1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Information1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2016Mechanical Problem; Collapse; Mechanical Problem
IT WAS REPORTED THAT ONE YEAR POST OP CT SCAN (ORIGINAL SURGERY DATE OF 8-18-15) SHOWS CAGE AT L4-5 STILL FULLY DISTRACTED. CAGE AT L5-S1 IS COMPLETELY COLLAPSED. PATIENT IS DOING FINE, EVIDENCE OF BONE GROWTH, SO SURGEON WILL CONTINUE TO FOLLOW PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5978372 ↗MalfunctionAug 22, 2016Mechanical Problem; Pressure Problem; Mechanical Problem
IT WAS REPORTED THAT; DURING INSERTION OF CAGE, IT WOULD NOT HOLD PRESSURE. UPDATE: THE EVENT OCCURRED ON (B)(6) 2016 REP CONFIRMED HE WAS NOT MADE AWARE OF THIS UNTIL (B)(6) 2016. THE SURGERY WAS COMPLETED USING ANOTHER CAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5894731 ↗InjuryMar 9, 2016Mechanical Problem; Collapse; Mechanical Problem
IT WAS REPORTED THAT THE CAGE COLLAPSED.
Patient problems: No Information; Pain
MAUDE report 5490160 ↗MalfunctionFeb 23, 2016Device Dislodged or Dislocated; Collapse; Device Dislodged or Dislocated; Noise, Audible
IT WAS REPORTED THAT THE PATIENT HEARD A LOUD POPPING NOISEAND REPORTED IT TO (B)(6) TOOK A SCAN AND REALIZED THAT THE CAGE HAD COLLAPSED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5455533 ↗
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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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