Fortress Pedicle Screw 10-10-48-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M7406406540), received between Sep 8, 2016 and Sep 8, 2016 — classified as 3 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjurySep 8, 2016Fracture; Fracture

  THE PATIENT UNDERWENT A 2-LEVEL SPINAL SURGICAL PROCEDURE ON (B)(6) 2014 WITH PLACEMENT OF SIX (6) FORTRESS PEDICLE SCREWS, SIX (6) FORTRESS SET SCREWS, AND TWO (2) FORTRESS RODS. AN UNSPECIFIED ANTERIOR INTERBODY FUSION WAS ALSO PLACED. AT AN UNSPECIFIED TIME FOLLOWING THE INITIAL IMPLANT PROCEDURE, THE PATIENT SUFFERED A FALL FOR UNKNOWN REASONS AND REPORTED "POPPING AND PAIN". CT IMAGING REVEALED THAT FOUR OF THE SIX PEDICLE SCREWS SUSTAINED SCREW SHANK FRACTURES. THE IMAGING ALSO REVEALED THAT THE INTERBODY DEVICE APPEARED TO BE "VERY WELL FUSED". ON (B)(6) 2016, THE PATIENT RETURNED TO SURGERY AT WHICH TIME ALL FORTRESS DEVICES WERE EXPLANTED. THE DISTAL SHANK ENDS OF THE FOUR BROKEN PEDICLE SCREWS WERE UNABLE TO BE RETRIEVED. SPINEOLOGY MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT; HOWEVER, ALL ATTEMPTS WERE UNSUCCESSFUL.

  Patient problems: Fall; Pain

  MAUDE report 5936490 ↗
• InjurySep 8, 2016Fracture; Fracture

  THE PATIENT UNDERWENT A 2-LEVEL SPINAL SURGICAL PROCEDURE ON (B)(6) 2014 WITH PLACEMENT OF SIX (6) FORTRESS PEDICLE SCREWS, SIX (6) FORTRESS SET SCREWS, AND TWO (2) FORTRESS RODS. AN UNSPECIFIED ANTERIOR INTERBODY FUSION WAS ALSO PLACED. AT AN UNSPECIFIED TIME FOLLOWING THE INITIAL IMPLANT PROCEDURE, THE PATIENT SUFFERED A FALL FOR UNKNOWN REASONS AND REPORTED "POPPING AND PAIN". CT IMAGING REVEALED THAT FOUR OF THE SIX PEDICLE SCREWS SUSTAINED SCREW SHANK FRACTURES. THE IMAGING ALSO REVEALED THAT THE INTERBODY DEVICE APPEARED TO BE "VERY WELL FUSED". ON (B)(6) 2016, THE PATIENT RETURNED TO SURGERY AT WHICH TIME ALL FORTRESS DEVICES WERE EXPLANTED. THE DISTAL SHANK ENDS OF THE FOUR BROKEN PEDICLE SCREWS WERE UNABLE TO BE RETRIEVED. SPINEOLOGY MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT; HOWEVER, ALL ATTEMPTS WERE UNSUCCESSFUL.

  Patient problems: Fall; Pain

  MAUDE report 5936488 ↗
• InjurySep 8, 2016Fracture; Fracture

  THE PATIENT UNDERWENT A 2-LEVEL SPINAL SURGICAL PROCEDURE ON (B)(6) 2014 WITH PLACEMENT OF SIX (6) FORTRESS PEDICLE SCREWS, SIX (6) FORTRESS SET SCREWS, AND TWO (2) FORTRESS RODS. AN UNSPECIFIED ANTERIOR INTERBODY FUSION WAS ALSO PLACED. AT AN UNSPECIFIED TIME FOLLOWING THE INITIAL IMPLANT PROCEDURE, THE PATIENT SUFFERED A FALL FOR UNKNOWN REASONS AND REPORTED "POPPING AND PAIN". CT IMAGING REVEALED THAT FOUR OF THE SIX PEDICLE SCREWS SUSTAINED SCREW SHANK FRACTURES. THE IMAGING ALSO REVEALED THAT THE INTERBODY DEVICE APPEARED TO BE "VERY WELL FUSED". ON (B)(6) 2016, THE PATIENT RETURNED TO SURGERY AT WHICH TIME ALL FORTRESS DEVICES WERE EXPLANTED. THE DISTAL SHANK ENDS OF THE FOUR BROKEN PEDICLE SCREWS WERE UNABLE TO BE RETRIEVED. SPINEOLOGY MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT; HOWEVER, ALL ATTEMPTS WERE UNSUCCESSFUL.

  Patient problems: Fall; Pain

  MAUDE report 5936486 ↗