OASYS 48552314Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04546540371683), received between Jul 26, 2016 and Apr 30, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21939289 ↗
• MalfunctionApr 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE TULIPS OF TWO OASYS POLYAXIAL SCREWS DISENGAGED INTRA-OPERATIVELY WHILE REMOVING THE SCREWS AND THAT THE SCREW SHANKS REMAIN IMPLANTED IN THE PATIENT. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21939283 ↗
• MalfunctionApr 3, 2020Mechanical Jam; Mechanical Jam

  STRYKER REPRESENTATIVE REPORTED THAT AN OASYS 3.5 X 14MM POLYAXIAL SCREW BECAME JAMMED AFTER STERILIZATION PRE-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH A REPLACEMENT DEVICE. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9924280 ↗
• MalfunctionOct 10, 2016Mechanical Problem; Device Dislodged or Dislocated; Break; Mechanical Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SCREW WAS BEING REMOVED AND TULIP RIPPED OFF. I HAVE ONLY THE TULIP AND AM RETURNING IT. THE SURGICAL DELAY WAS TEN MINUTES WHILE THEY HAD TO GET THE SCREW SHANK OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6015666 ↗
• MalfunctionSep 26, 2016Mechanical Problem; Detachment Of Device Component; Mechanical Problem

  IT WAS REPORTED THAT THE SURGEON PERFORMED AN OCCIPUT-T2 REVISION/EXTENSION TO T3.(CAPTURED IN (B)(4)). SURGEON'S PRE-OP PLAN WAS TO REMOVE AND RE-INSTRUMENT C1, T1, T2 AND EXTEND AND ADD SCREWS TO T3. ALONG WITH THIS, HE PLANNED TO HARVEST A RIB AND WIRE IT BETWEEN THE C1 ARCH AND SPINOUS PROCESS. LASTLY, CHECKING SCREWS FOR GENERAL PURCHASE AND POTENTIALLY ADJUSTING THE OCCIPITAL PLATE IF NEEDED. HE REMOVED AND RE-INSTRUMENTED ACCORDING TO PLAN WITH C1, T2 & T3. HE PLACED 5.5MM SCREWS INTO T2 & T3. HE ALSO REMOVED 3 BONES SCREWS FROM THE OCCIPITAL PLATE, ALL OF WHICH WERE 4.5MM RESCUE SCREWS TO BEGIN WITH. THIS ALLOWED HIM WITH NO RESCUE BUT TO SIMPLY ADD 2MM TO THE LENGTH AND RE-INSTRUMENT. HE THEN STARTED TO BEND HIS FIRST VITALLIUM ROD FOR THE LEFT SIDE OF THE CONSTRUCT. HE BEGAN PERSUADING THE ROD USING A GUN PERSUADER AND ROD FORK. HE PLACED 3 OR 4 BLOCKERS AND WAS WORKING HIS WAS UP TO C3 WHEN THE TULIP OF HIS C3 SCREW POPPED OFF OF THE SCREW SHANK. HE THEN HAD TO REMOVE THE BLOCKERS AND FISH OUT THE SHANK. HE ATTEMPTED TO PLACE A 4.5X24MM RESCUE SCREW WHERE THAT SCREW PREVIOUSLY WAS BUT WAS HAVING TROUBLE ADVANCING THE SCREW AFTER IT WAS ABOUT HALFWAY IN. IT THEN CROSS-THR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5978439 ↗
• InjuryAug 17, 2016Mechanical Problem; Difficult To Position; Malposition of Device; Mechanical Problem; Difficult To Position

  IT WAS REPORTED THAT AN ANGLE SCREW PLACED IN CERVICAL SPINE, ROD PLACED ON CONSTRUCT, BLOCKER PLACED, FINAL TIGHTENED. X-RAY TAKEN, SURGEON WAS UNHAPPY WITH THE SCREW, THEREFORE WANTED TO REPOSITION IT. THE SCREW WAS NO LONGER POLYAXIAL AND FIXED IN POSITION, SCREWDRIVER UNABLE TO ENGAGE WITH SCREW, OR POLY ADJUSTMENT DRIVER. THEREFORE SCREW HAD TO BE TURNED AND PULLED OUT, DAMAGE TO JOINT OF CERVICAL BONE. SCREW INSPECTED BY REP, IT APPEARS THE SHANK OF THE SCREW HAS BEEN PUSHED DOWN AND ALMOST POPPED THROUGH THE TULIP HEAD, THEREFORE FIXED IN POSITION.

  Patient problems: Injury; Tissue Damage

  MAUDE report 5884476 ↗
• MalfunctionJul 28, 2016Difficult to Insert; Mechanical Problem; Failure to Advance; Mechanical Jam; Difficult to Insert; Mechanical Problem

  IT WAS REPORTED THAT; SURGEON COULD NOT ADVANCE OR BACK OUT SCREW AFTER INITIALLY BEING INSERTED. SURGEON USED POLYAXIAL DRIVER THEN USED SCREWDRIVER AND COULD NOT ADJUST SCREW. HAD TO HELICOPTER SCREW OUT TWICE. UPDATE; THERE WAS OVER AN HOUR SURGICAL DELAY TO HELICOPTER OUT SCREWS THEN RE INSERT THEM. (2X)

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5829179 ↗
• InjuryJul 28, 2016Difficult to Insert; Mechanical Problem; Difficult to Remove; Failure to Advance; Difficult to Insert; Mechanical Problem

  IT WAS REPORTED THAT; SURGEON COULD NOT ADVANCE OR BACK OUT SCREW AFTER INITIALLY BEING INSERTED. SURGEON USED POLYAXIAL DRIVER THEN USED SCREWDRIVER AND COULD NOT ADJUST SCREW. HAD TO HELICOPTER SCREW OUT TWICE. UPDATE; THERE WAS OVER AN HOUR SURGICAL DELAY TO HELICOPTER OUT SCREWS THEN RE INSERT THEM. (2X)

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

  MAUDE report 5829177 ↗
• MalfunctionJul 26, 2016Break

  IT WAS REPORTED THAT THE SCREWS STRIPPED DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5821838 ↗