OLYMPIC ABAA00055Recalls & reported problems
Astura Medical · SET SCREW · Class 2
- 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 00841379131212), received between May 6, 2022 and Feb 9, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated2
Patient problems
- Failure of Implant1
- Implant Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
THREE SET SCREWS BACKED OUT REQUIRING A REVISION SURGERY.
Patient problems: Implant Pain
MAUDE report 18676594 ↗MalfunctionMay 6, 2022Device Dislodged or Dislocated
PATIENT HAD A SPINAL FUSION SURGERY PERFORMED ON (B)(6) 2020. DURING A FOLLOW-UP IT WAS OBSERVED THAT SOME OF THE LOCKING SET SCREWS HAD BECOME DISLODGED FROM THE PEDICLE SCREWS. A REVISION SURGERY WAS PERFORMED TO REPLACE THE LOCKING SCREWS. NO INJURY TO THE PATIENT AS A RESULT OF THE EVENT.
Patient problems: Failure of Implant
MAUDE report 14310089 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.