gSource gS 78.5824Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840314240934), received between May 6, 2026 and May 6, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• InjuryMay 6, 2026Break

  WHILE PLACING SCREWS FOR AN SI-JOINT FUSION, STEINMANN PIN BROKE, LLAVING AND 8MM RETAINED PIN FRAGMENT. THE PIN TIP COULD NOT BE REMOVED (FRAGMENT). IT WAS NEAR THE NERVE ROOT. THE PATIENT HAD RESULTED LS NEUROPRAXIA AND WEAK EXTENSORS OF HER FOOT AS A RESULT. DUE TO THE LOCATION OF THE RETAINED PIN , IT WOULD BE INADVISABLE TO REMOVE THE PIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 25093936 ↗