TIGER SHARK SYSTEM S-PT47-25106Recalls & reported problems
Choice Spine, LP · TIGERSHARK THTL,STERILE,11X25X10X6DEG · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840996186834), received between Feb 17, 2023 and Feb 17, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 18, 2026.
Most reported problems
Device problems
- Migration or Expulsion of Device1
Patient problems
- Unspecified Musculoskeletal problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2023Migration or Expulsion of Device; Migration or Expulsion of Device
ON (B)(6) 2022, WE HAD TO BRING A PATIENT TO SURGERY TO REMOVE A TIGER SHARK THREADED TL CAGE FROM L5-S1 THAT MOVED FROM THE DISC SPACE AND WAS CAUSING PAIN TO THE PATIENT. THE PATIENT HAD A 1-LEVEL FUSION ON (B)(6) 2022. X-RAY CONFIRMED THAT THE CAGE WAS.
Patient problems: Unspecified Musculoskeletal problem
MAUDE report 16395663 ↗
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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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