OASYS 48558528Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04546540596444), received between Mar 21, 2016 and Apr 4, 2022 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2022Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE SCREW INSERTION, THE TULIP OF AN OASYS SCREW DISENGAGED FROM THE SCREW SHANK. IN ORDER TO REMOVE THE SCREW SHANK THE PATIENT'S BONE HAD TO BE "DRILLED AWAY" FROM AROUND THE IMPLANTATION SITE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14003057 ↗
• InjuryJan 3, 2020Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT TWO OASYS POLYAXIAL SCREW HEADS FRACTURED INTRA-OPERATIVELY. THE SURGERY RESULTED IN 60 MINUTE SURGICAL DELAY. THIS RECORD REPRESENTS THE FIRST SCREW.

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

  MAUDE report 9545319 ↗
• InjuryJan 3, 2020Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT TWO OASYS POLYAXIAL SCREW HEADS FRACTURED INTRA-OPERATIVELY. THE SURGERY RESULTED IN 60 MINUTE SURGICAL DELAY. THIS RECORD REPRESENTS THE SECOND SCREW.

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

  MAUDE report 9545306 ↗
• MalfunctionMar 11, 2019Fracture; Detachment of Device or Device Component; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, HEAD OF POLY AXIAL SCREW POPPED OFF. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY OR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8409953 ↗
• MalfunctionJan 8, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE, SCREW BROKE AND TULIP HEAD POPPED OFF. THERE WAS A SURGICAL DELAY OF 5 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED.

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

  MAUDE report 8225911 ↗
• MalfunctionJun 24, 2018Break; Entrapment of Device; Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING IMPLANTATION OF A SCREW INTO THE T2 PEDICLE, THE TULIP HEAD DISENGAGED. THE REMAINING SCREW COULD NOT BE REMOVED AND THE CONSTRUCT REMAINED IN THE PATIENT. THE SURGERY HAD TO BE TERMINATED AT T1 INSTEAD OF T2 ON THE RIGHT SIDE WHILE THE LEFT SIDE WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

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

  MAUDE report 7632693 ↗
• MalfunctionAug 21, 2017Material Deformation; Material Integrity Problem; Break; Detachment Of Device Component; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT; DURING SURGERY WHILE PLACING IN A T1 PEDICLE SCREW WITH A CUSTOM RATCHETING SCREW DRIVER, AN OASYS SCREW TULIP HEAD BROKE OFF. THE SCREW HOLES WERE PREPARED WITH A GEAR SHIFT AND A TAP AND THE PATIENT HAD GOOD BONE QUALITY. THE SURGEON USED A VICE GRIP TO REMOVE THE SCREW AND ALL BROKEN FRAGMENTS WERE RETRIEVED. THE SAME SIZE SCREW USED WAS TO SUCCESSFULLY COMPLETE THE SURGERY. THERE WAS 40 MINUTES SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

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

  MAUDE report 6809365 ↗
• MalfunctionAug 10, 2017Mechanical Problem; Device Dislodged or Dislocated; Break; Mechanical Problem; Device Dislodged or Dislocated

  IT IS REPORTED THAT WHEN INSERTING A SCREW INTO T2 THE POLY HEAD POPPED OFF THE BONE SCREW.

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

  MAUDE report 6786687 ↗
• MalfunctionNov 18, 2016Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT A SCREW TULIP HEAD BROKE APART FROM THE SCREW THREADS WHILE IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6112867 ↗
• MalfunctionNov 15, 2016Mechanical Problem; Device Dislodged or Dislocated; Break; Detachment Of Device Component; Mechanical Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT; PERFORMING A POSTERIOR CERVICAL FUSION OF THE C3 TO T2, WE HAD PLACED ALL 10 OF 3.5X12MM SCREWS IN C3 - C7. WE THEN PLACED 3 OF THE 4 OF THE 4.5 X 28MM SCREWS. TWO WERE PLACED IN AT BOTH THE LEFT AND RIGHT PEDICLES OF T1 AND THEN WE HAD A SCREW IN ALREADY INSERTED AT T2 ON THE LEFT SIDE. THE SURGEON WAS INSERTING THE FINAL SCREW 4.5X26MM SCREW IN A T T2 AND AS HE WAS TIGHTENING, THE SCREW HEAD BROKE OFF, LEAVING THE MAJORITY OF THE THREAD INSIDE THE VERT BODY. WE DID NOT HAVE A UNIVERSAL REMOVAL KIT AT THE TIME AND HAD TO USE A SET TO REMOVE THE ENTIRE THREAD. WE ALSO USED ALL THE 4.5 X 28MM SCREWS, SO WE HAD TO RESORT TO USING A 4.5X24MM SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6104707 ↗
• MalfunctionSep 26, 2016Detachment Of Device Component

  IT WAS REPORTED THAT TULIP HEADS POPPED OFF THREE SCREWS DURING SCREW INSERTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5978592 ↗
• MalfunctionSep 26, 2016Mechanical Problem; Detachment Of Device Component; Mechanical Problem

  IT WAS REPORTED THAT TULIP HEADS POPPED OFF THREE SCREWS DURING SCREW INSERTION

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5978330 ↗
• MalfunctionSep 26, 2016Detachment Of Device Component

  IT WAS REPORTED THAT TULIP HEADS POPPED OFF THREE SCREWS DURING SCREW INSERTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5978328 ↗
• InjuryMay 10, 2016Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SURGEON PERFORMED A C2-T1 PCF. WHEN HE PLACED THE T1 SCREW ON THE RIGHT SIDE, HE USED A RADIUS THORACIC SHARP PROBE, TAPPED WITH A 3.5MM TAP, THEN BEGAN IMPLANTING A 4.5X28MM NON-BIASED SCREW. AS HE WAS FINISHING THE SCREW INSERTION, THE TULIP HEAD OF THE SCREW DETACHED FROM THE BONE SCREW, BREAKING THE SCREW. AS A RESULT, THE SURGEON WAS FORCED TO EXTEND HIS INCISION TO T2 TO PLACE SCREWS AND ATTACH RODS. THIS CAUSED A 45 MINUTES OF ADDITIONAL SURGICAL TIME.

  Patient problems: No Information

  MAUDE report 5645532 ↗
• MalfunctionMar 29, 2016Break

  IT WAS REPORTED THAT A NON BIASED PEDICLE SCREW STRIPPED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5532457 ↗
• MalfunctionMar 21, 2016Material Deformation; Material Integrity Problem; Break; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT THE SCREW WAS STRIPPED AND THE ROD HAD TO BE CUT IN ORDER TO REMOVE IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5514622 ↗