ASTRA Spine System A5S-T30Recalls & reported problems
Spinecraft, LLC · T30 Set Screw · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M824A5ST301), received between May 10, 2016 and Mar 24, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 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
- Loose or Intermittent Connection2
Patient problems
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2017Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS DISCOVERED ON A POST-OP FOLLOW UP VISIT THAT ONE OF THE SET SCREWS IS LOOSE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6431316 ↗MalfunctionMay 10, 2016Loose or Intermittent Connection; Loose or Intermittent Connection
SURGEON PERFORMED A REVISION SURGERY ON (B)(6) 2016 TO REPLACE A SET SCREW THAT WAS DISCOVERED TO BE LOOSE. THE ORIGINAL SURGERY WAS COMPLETED ON (B)(6) 2016.
Patient problems: Pain
MAUDE report 5645754 ↗
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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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