SFS;SFS LE;SFS SCOLI 56-3635Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18257200055739), received between Feb 11, 2016 and Feb 11, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

1 other recall cover devices cleared under the same FDA submission (K080407); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2016Detachment Of Device Component

  INFORMATION PROVIDED STATES THAT THE PRESSURE CAP CAME OFF OF THE SCREW DURING A CASE. THE SURGEON REMOVED THE SCREW AND PLACED ANOTHER OF THE SAME SIZE.

  Patient problems: No Code Available

  MAUDE report 5432488 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080407. One submission often covers many models, so check the product and lot details in each record.

• Z-0896-2013 · Feb 1, 2013 · Terminated
  Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod components to be conne