OASYS 48558532Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540596451), received between May 17, 2016 and Aug 27, 2021 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE TULIP OF AN OASYS POLYAXIAL SCREW DID NOT ENGAGE WITH THE OASYS POLYAXIAL SCREWDRIVERS DURING REPOSITIONING AT C7 INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. NO ADVERSE CONSEQUENCES NOR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12378326 ↗
• MalfunctionSep 23, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT TWO OASYS NON BIASED POLYAXIAL SCREW TULIPS DISENGAGED INTRA-OPERATIVELY DURING A SCHEDULED EXTENSION. DURING SCREW REMOVAL, THE TULIP HEADS POPPED OFF FROM THE SCREW SHANKS. THE SURGEON WAS ABLE TO REMOVE THE SCREW SHANKS AND COMPLETE THE SURGERY WITHOUT HARM TO THE PATIENT. THE EVENT DID RESULT IN A 45 MINUTE SURGICAL DELAY. THIS REPORT REPRESENTS THE FIRST OF THE TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10573464 ↗
• MalfunctionSep 23, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT TWO OASYS NON BIASED POLYAXIAL SCREW TULIPS DISENGAGED INTRA-OPERATIVELY DURING A SCHEDULED EXTENSION. DURING SCREW REMOVAL, THE TULIP HEADS POPPED OFF FROM THE SCREW SHANKS. THE SURGEON WAS ABLE TO REMOVE THE SCREW SHANKS AND COMPLETE THE SURGERY WITHOUT HARM TO THE PATIENT. THE EVENT DID RESULT IN A 45 MINUTE SURGICAL DELAY. THIS REPORT REPRESENTS THE SECOND OF THE TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10573462 ↗
• MalfunctionNov 14, 2016Mechanical Problem; Detachment Of Device Component; Mechanical Problem

  IT WAS REPORTED THAT; THE TULIP HEAD OF A 4.5 SCREW POPPED OFF WHILE IMPLANTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6100729 ↗
• MalfunctionSep 13, 2016Break; Detachment Of Device Component; Mechanical Problem; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A POSTERIOR THORACIC REVISION CASE WHILE REMOVING A SCREW, THE TULIP HEAD SNAPPED OFF LEAVING THE THREAD IMPLANTED. ADDITIONALLY, WHILE REMOVING IMPLANTS, SEVERAL INSTRUMENTS WERE DAMAGED/STRIPPED OR BROKEN.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5945561 ↗
• MalfunctionMay 17, 2016Break; Detachment Of Device Component; Mechanical Problem; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT; THE TULIP HEAD BROKE OFF OF SCREW AT T1. THE OTHER SCREW ALSO AT T1 WAS STRIPPED AND UNABLE TO BE REMOVED OR ADVANCED FURTHER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5661390 ↗
• InjuryMay 17, 2016Break; Mechanical Problem; Difficult to Remove; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT; THE TULIP HEAD BROKE OFF OF SCREW AT T1. THE OTHER SCREW ALSO AT T1 WAS STRIPPED AND UNABLE TO BE REMOVED OR ADVANCED FURTHER. UPDATE (26-APR-2016): THE STRIPPED SCREW REMAINS IN PATIENT. THE DETACHED TULIP FORCED HIM TO ADD EXTRA LEVEL WHICH ADDED 45 MIN TO CASE.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 5661383 ↗