ASTRA Spine System A5P-8580Recalls & reported problems
Spinecraft, LLC · ASTRA Ti Polyaxial Screw 8.50 x 80mm · Class 2 · Implant
Data updated Oct 16, 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 M824A5P85801), received between Oct 4, 2018 and Oct 4, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 4, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS FOUND TWO WEEKS POST-OP ON X-RAY THAT AN ILIAC SCREW HEAD AT THE BOTTOM OF A LONG CONSTRUCT WAS DISENGAGED FROM THE SHAFT. THE SURGEON DECIDED TO PERFORM A REVISION SURGERY AT A LATER DATE.
Patient problems: No Code Available
MAUDE report 7937073 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 reports
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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