OASYS 48556328Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540469731), received between Sep 28, 2016 and May 9, 2017 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2017Disconnection; Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE POST OP IMAGES SHOW A ROD THAT HAS IS NOT CONNECTED TO THE SCREW. ADDITIONAL INFORMATION: "THE REVISION SURGERY OCCURRED ON (B)(6).

  Patient problems: Failure of Implant; Injury

  MAUDE report 6555642 ↗
• InjuryMar 23, 2017Detachment Of Device Component; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT HAD A C1-C4 FIXATION IN (B)(6) 2016 WITH SMOOTH SHANK SCREWS AT C1 AND BIASED ANGLE SCREWS BILATERALLY AT C3 AND C4. SURGERY WAS TO STABILISE A LYTIC LESION AT C2. THE PATIENT REAPPEARED TO THE SURGEON THIS WEEK WITH BOTH C1 SCREWS SNAPPED AT THE POINT BETWEEN THE SMOOTH SHANK AND THE THREADED PART OF THE SCREW. REVISION SURGERY HAS BEEN UNDERTAKEN, WHICH INVOLVED REMOVAL OF THE TOP BROKEN SCREWS AND EXTENSION TO THE OCCIPUT.

  Patient problems: Injury; No Code Available

  MAUDE report 6427464 ↗
• MalfunctionMar 23, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT HAD A C1-C4 FIXATION IN (B)(6) 2016 WITH SMOOTH SHANK SCREWS AT C1 AND BIASED ANGLE SCREWS BILATERALLY AT C3 AND C4. SURGERY WAS TO STABILISE A LYTIC LESION AT C2. THE PATIENT REAPPEARED TO THE SURGEON THIS WEEK WITH BOTH C1 SCREWS SNAPPED AT THE POINT BETWEEN THE SMOOTH SHANK AND THE THREADED PART OF THE SCREW. REVISION SURGERY HAS BEEN UNDERTAKEN, WHICH INVOLVED REMOVAL OF THE TOP BROKEN SCREWS AND EXTENSION TO THE OCCIPUT.

  Patient problems: Injury; No Code Available

  MAUDE report 6427456 ↗
• InjurySep 28, 2016Mechanical Problem; Fracture; Mechanical Problem

  IT WAS REPORTED THAT THE SURGEON PERFORMED AN OCCIPUT-T2 REVISION/EXTENSION TO T3. THERE WAS A FRACTURED C1 SMOOTH SHANK SCREW (3.5X28MM) IN WHICH THE TULIP HEAD WAS COMPLETELY DISPLACED FROM THE SHANK. DURING THE REVISION SURGERY, AFTER GAINING ACCESS, THE SURGEON PROCEEDED TO REMOVE 18 TOTAL BLOCKERS FROM THE CONSTRUCT. HE VERBALLY NOTED THAT MULTIPLE BLOCKERS WERE LOOSE UPON REMOVAL. HE THEN REMOVED BOTH VITALLIUM RODS (2 OFFSET CONNECTORS INCLUDED). AFTER REMOVING HIS RODS HE HAD TO FISH OUT THE SCREW THREADING OF THE C1 SMOOTH SHANK SCREW THAT WAS FRACTURED.

  Patient problems: Injury; No Code Available

  MAUDE report 5984102 ↗