OASYS 48552318Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540371706), received between Sep 26, 2016 and Feb 24, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2017Break; Detachment Of Device Component; Disconnection; Difficult to Remove; Disconnection

  IT WAS REPORTED THAT; SURGEON STRUGGLED TO BACK OUT SCREW AFTER INITIALLY INSERTED. 20MIN DELAY. HEAD OF SCREW EVENTUALLY BROKE OFF. SURGEON SAID INNER HEAD OF SCREW STRIPPED AND SCREWDRIVER WAS NO LONGER EFFECTIVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6358180 ↗
• MalfunctionSep 26, 2016Mechanical Problem; Detachment Of Device Component; Mechanical Problem; Failure to Advance

  IT WAS REPORTED THAT THE SURGEON PERFORMED AN OCCIPUT-T2 REVISION/EXTENSION TO T3.(CAPTURED IN (B)(6)). 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 5978467 ↗