TIGER SHARK SYSTEM S-PT50-A3205Recalls & reported problems
Choice Spine, LP · TIGERSHARK M,STERILE,SPACER,32LX5H · 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 00840996188968), received between Apr 11, 2025 and Apr 11, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration” (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.
Reports received per month
Most reported problems
Device problems
- Migration1
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.
MalfunctionApr 11, 2025Migration; Migration
DR. PERFORMED AN L4 TO S1 POSTERIOR DECOMPRESSION AND FUSION WITH TLIF L4/L5 USING THE TSM IMPLANTS ON (B)(6) 2024. ON (B)(6) 2025, I RECEIVED X-RAYS AND A NOTIFICATION OF HIS INTENT TO REVISE THE PATIENT DUE TO POSTERIOR MIGRATION OF THE S-PT50-A3205 (32X5MM) SPACER. ON (B)(6) 2025, DR. (B)(6) PERFORMED THE REVISION SURGERY. HE MADE HIS INCISION AND EXPOSED THE POSTERIOR ASPECT OF THE TSM SPACER. HE FIRST ATTEMPTED TO MALLET IT ANTERIORLY. THE SPACER DID NOT MOVE WITH RESPECT TO THE TSM ENDPLATES. HE THEN USED THE TSM SPACER REMOVAL INSTRUMENT WITH THE SLAP HAMMER. AFTER SEVERAL ATTEMPTS, HE WAS ABLE TO REMOVE THE TSM SPACER FROM THE TSM ENDPLATES AND FROM THE PATIENT. HE WAS THEN ABLE TO USE A PITUITARY TO GRAB THE TSM ENDPLATES AND REMOVE THEM. HE IMPLANTED A 32MM (LENGTH) X 11MM (WIDTH) X 14MM (HEIGHT), 6-DEGREE TIGERSHARK STRAIGHT CAGE IN THE DISC SPACE WHERE THE TSM IMPLANTS WERE REMOVED. HE COMPRESSED ON THE CAGE USING THE PEDICLE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21830011 ↗
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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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