Fortress Set Screw w/ Pedicle Screw 10-10-48-XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M7406401005), received between Jul 15, 2016 and Jul 15, 2016 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Disassembly” (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 18, 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.

• MalfunctionJul 15, 2016Disassembly; Disassembly

  THE PHYSICIAN PERFORMED AN L4-L5 POSTERIOR FUSION SURGICAL PROCEDURE ON (B)(6) 2016. APPROXIMATELY 4 WEEKS FOLLOWING THE SURGICAL PROCEDURE, DURING A ROUTINE FOLLOW-UP VISIT RADIOGRAPHIC IMAGES REVEALED THAT BOTH OF THE CEPHALAD SET SCREWS HAD BECOME LOOSE AND SEPARATED FROM THE TULIP HEADS OF THE CORTICAL SCREWS. THE PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2016 AT WHICH TIME THE TWO CAUDAL SET SCREWS WERE ASSESSED AND DETERMINED TO BE TIGHT. THE SPINAL CONSTRUCT WAS DIASSEMBLED AND THE CORTICAL SCREWS WERE MANUALLY MANIPULATED AND DETERMINED TO BE TIGHT WITH NO EVIDENCE OF LOOSENING. THE SPINAL CONSTRUCT WAS REASSEMBLED USING THE PREVIOUSLY IMPLANTED CORTICAL SCREWS, TWO NEW RODS, AND FOUR NEW SET SCREWS. ON (B)(6) 2016, THE PATIENT WAS REPORTED TO BE "DOING VERY WELL".

  Patient problems: No Information

  MAUDE report 5798135 ↗
• MalfunctionJul 15, 2016Disassembly; Disassembly

  THE PHYSICIAN PERFORMED AN L4-L5 POSTERIOR FUSION SURGICAL PROCEDURE ON (B)(6) 2016. APPROXIMATELY 4 WEEKS FOLLOWING THE SURGICAL PROCEDURE, DURING A ROUTINE FOLLOW-UP VISIT RADIOGRAPHIC IMAGES REVEALED THAT BOTH OF THE CEPHALAD SET SCREWS HAD BECOME LOOSE AND SEPARATED FROM THE TULIP HEADS OF THE CORTICAL SCREWS. THE PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2016 AT WHICH TIME THE TWO CAUDAL SET SCREWS WERE ASSESSED AND DETERMINED TO BE TIGHT. THE SPINAL CONSTRUCT WAS DISSEMBLED AND THE CORTICAL SCREWS WERE MANUALLY MANIPULATED AND DETERMINED TO BE TIGHT WITH NO EVIDENCE OF LOOSENING. THE SPINAL CONSTRUCT WAS REASSEMBLED USING THE PREVIOUSLY IMPLANTED CORTICAL SCREWS, TWO NEW RODS, AND FOUR NEW SET SCREWS. ON (B)(6) 2016, THE PATIENT WAS REPORTED TO BE "DOING VERY WELL".

  Patient problems: No Information

  MAUDE report 5798124 ↗