OASYS 48558520Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540596420), received between Jul 26, 2016 and Nov 21, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2017Break; Detachment Of Device Component; Battery Problem; Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT; 4.5X20MM NON-BIASED SCREW BROKE OFF JUST BELOW THE HEAD DURING INSERTION AT L C7. A 2.5 DRILL WAS USED WITH THE VARIABLE DRILL GUIDE SET TO 20. THE 3.5 TAP WAS USED BUT THE SURGEON TOOK OFF THE TAP SLEEVE AND DID NOT TAP TO THE FULL DEPTH. THE 4.5X20MM NON-BIASED SCREW WAS PROPERLY LOADED ONTO A T-BAR DRIVER AND THEN LOCKED INTO THE POWER DRILL. THE SURGEON THEN BEGAN INSERTION OF THE SCREW INTO THE PEDICLE. THE DRILL STOPPED ABRUPTLY AND IT APPEARED THAT THE BATTERY WAS DEAD. WE CALLED FOR ANOTHER BATTERY AND THE SURGEON DECIDED TO USE THE HAND RATCHET TO FINISH INSERTION OF THE SCREW. HE ATTEMPTED TO HAND DRIVE THE SCREW IN AND WHEN HE DID THE TOP OF THE SCREW (JUST BELOW THE HEAD) BROKE OFF. THE SURGEON CALLED FOR THE SCREW EXTRACTION TRAY AND WAS FINALLY ABLE TO GET THE BOTTOM OF THE SCREW SHAFT OUT OF THE PATIENT AFTER A FEW ATTEMPTS. THE SURGEON MADE THE COMMENT THAT HE FEELS HE MAY NOT HAVE TAPPED DEEP ENOUGH AND THAT THE PATIENTS BONE WAS VERY DENSE. HE THEN ASKED FOR ANOTHER 4.5X20MM NON-BIASED SCREW AND WE LOADED THIS SCREW ONTO THE T-BAR DRIVER AND PLACED IT ON POWER. THE SURGEON THEN BEGAN INSERTION OF THE SECOND SCREW INTO THE SAME TRAJECTORY AS T

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

  MAUDE report 7049718 ↗
• MalfunctionMay 9, 2017Material Deformation; Material Integrity Problem; Material Deformation

  IT WAS REPORTED THAT; SCREWS KEPT STRIPPING AS SOON AS ANY RESISTANCE WAS FELT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6553968 ↗
• MalfunctionJul 26, 2016Material Deformation; Torn Material; Material Deformation

  IT WAS REPORTED THAT THE SCREWS STRIPPED DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5821869 ↗