OASYS 48551071Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540596086), received between Nov 15, 2016 and Mar 13, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2017Break; Detachment Of Device Component; Fracture; Fracture

  IT WAS REPORTED THAT; DURING TIGHTENING OF TRANSVERSE CROSS CONNECTOR BOTTOM TABS BROKE OFF. THIS HAPPENED 8-10 TIMES WITH ALL SIZES OF CROSS CONNECTORS. PROPER TECHNIQUE WAS FOLLOWED DURING TIGHTENED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6399899 ↗
• MalfunctionMar 13, 2017Break; Fracture; Fracture

  IT WAS REPORTED THAT; DURING TIGHTENING OF TRANSVERSE CROSS CONNECTOR BOTTOM TABS BROKE OFF. THIS HAPPENED 8-10 TIMES WITH ALL SIZES OF CROSS CONNECTORS. PROPER TECHNIQUE WAS FOLLOW DURING TIGHTENED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6399637 ↗
• MalfunctionNov 15, 2016Fracture; Break; Fracture

  IT WAS REPORTED THAT; WHEN TORQUING THE TRANSVERSE CONNECTOR SET SCREW, THE TRANSVERSE CONNECTOR BROKE. IT WAS THE PIECE THAT SNAPS ONTO THE ROD THAT BROKE. THE COUNTER TORQUE WAS USED. ALL OTHER BLOCKERS WERE FINAL TIGHTENED. THE SET SCREW WAS REMOVED FROM THE CONNECTOR, AND THE ENTIRE CONNECTOR WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6104746 ↗