TIGER SHARK SYSTEM S-PT50-A3204Recalls & reported problems
Choice Spine, LP · TIGERSHARK M,STERILE,SPACER,32LX4H · 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 00840996188951), received between Jan 8, 2025 and Jan 8, 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
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2025Migration; Migration
THE SURGEON PROVIDED POSTOPERATIVE IMAGES OF A TIGERSHARK M CAGE WHERE THE SPACER MOVED POSTERIORLY FROM ITS POSITION DURING THE ORIGINAL SURGERY. THE DR. IS PLANNING ON REVISING THE IMPLANT ON (B)(6) 2024.THE TSM IMPLANTATION SURGERY OCCURRED ON (B)(6) 2024. THE PROCEDURE WAS AN L4/L5 TLIF. THE IMPLANTS USED WERE 32MM LENGTH, 6-DEGREE ENDPLATES (S-PT50-E3206, 11590-02) AND A 32MM X 4MM SPACER (S-PT50-A3204, 10455-35). IN THE INITIAL SURGERY, THE DR. ATTEMPTED TO INSERT A 5MM SPACER (S-PT50-A3205, 10492-18). HOWEVER, THE EXPANSION RESISTANCE CAUSED THE SPACER INSERTER TO DISASSOCIATE FROM THE INSERTION RAILS TWICE, PREVENTING THE SUCCESSFUL MATING OF THE ENDPLATES WITH THE SPACER. THE 5MM SPACER WAS BACKED OUT AND THE SPACER INSERTER WAS REMOVED FROM THE INSERTION RAILS. HE THEN REQUESTED A 4MM SPACER. THE 4MM SPACER WAS ATTACHED TO THE SPACER INSERTER AND THE SPACER INSERTER, WITH THE 4MM SPACER, WAS ATTACHED TO THE INSERTION RAILS AND ADVANCED TO EXPAND THE IMPLANT. THE EXPANSION AND MATING OF THE 4MM SPACER WITH THE ENDPLATES WAS SUCCESSFUL WITHOUT ANY OBSERVED ISSUES. IT WAS NOTED DURING THE CASE THAT THE CAM LOCKING STEP WENT AS EXPECTED AND IT WAS FELT AT THAT TIME THAT THE C
Patient problems: Insufficient Information
MAUDE report 21106458 ↗
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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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