OASYS 48551070Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04546540371607), received between Mar 29, 2016 and Nov 7, 2018 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2018Fracture; Break; Fracture

  IT WAS REPORTED THAT THE TRANSVERSE CONNECTOR BROKE DURING TIGHTENING. IT WAS REPORTED THAT THE SURGEON WAS USING THE FINAL TIGHTENER WITHOUT THE USE OF THE ANTI-TORQUE. SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8048498 ↗
• MalfunctionSep 5, 2018Break; Fracture; Fracture

  WHEN TIGHTENING THE TRANSVERSE CONNECTOR WITH TORQUE WRENCH, THE CONNECTOR BROKE. THE TRANSVERSE CONNECTOR WAS REPLACED WITH ANOTHER SAME NEW ONE. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7848016 ↗
• MalfunctionMay 29, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT THE TRANSVERSE CONNECTOR BROKE AT THE TIME OF FINAL TIGHTENING OF BLOCKER WITH TORQUE WRENCH. BLOCKER WAS IN INSIDE OF TRANSVERSE HEAD. THE SURGEON CHANGED IT WITH A NEW ONE AND SURGERY SUCCEEDED. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7551260 ↗
• MalfunctionMay 1, 2018Fracture; Break; Fracture

  IT WAS REPORTED THAT WHEN THE TRANSVERSE CONNECTOR WAS FINAL TIGHTENED, IT WAS BROKEN. THE CONNECTOR WAS REPLACED WITH A NEW ONE AND THE OPERATION WAS CONTINUED. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7474971 ↗
• MalfunctionOct 31, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; WHEN FINAL TIGHTENING THE TRANSVERSE CONNECTOR, THE BOTTOM WHERE IT CONNECTS TO THE ROD SNAPPED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6990915 ↗
• MalfunctionApr 12, 2017Break; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE TRANSVERSE CONNECTOR WAS BROKEN DURING FINAL TIGHTENING AND THEY WERE REMOVED FROM THE PATIENT. THE SURGEON CHANGED IT WITH THE NEW ONE AND THE SURGERY SUCCEEDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6485502 ↗
• 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 6400160 ↗
• 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 OF CROSS CONNECTORS. PROPER TECHNIQUE WAS FOLLOW DURING TIGHTENED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6399649 ↗
• MalfunctionMar 13, 2017Break; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 6399648 ↗
• MalfunctionMar 13, 2017Break; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 6399643 ↗
• 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 6399642 ↗
• MalfunctionMar 13, 2017Break; Detachment Of Device Component; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 6399640 ↗
• 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 FOLLOW DURING TIGHTENED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6399639 ↗
• MalfunctionMar 29, 2016Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A SURGERY, A PART OF A CONNECTOR BROKE WHEN THE SURGEON TIGHTEN IT FINALLY. THE SURGEON USED OTHER ONE AND FINISHED THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5532376 ↗