EXPEDIUM SFXRecalls & reported problems across all models

We found 14 models of EXPEDIUM SFX by Depuy Spine, LLC in the FDA's device registry (GUDID). Together they are named in 201 adverse event reports in the FDA's MAUDE database, received between Sep 29, 2017 and Jun 26, 2026 — classified as 23 injuries, 178 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (73 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported EXPEDIUM SFX problems

EXPEDIUM SFX models

14 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EXPEDIUM SFX 289410300

  DRIVER, PROSTHESIS
  103 reports
• EXPEDIUM SFX 289410150

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  49 reports
• EXPEDIUM SFX 189401406

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  15 reports
• EXPEDIUM SFX 189401405

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  10 reports
• EXPEDIUM SFX 189401404

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  6 reports
• EXPEDIUM SFX 189401303

  Pedicle screw spinal system, adolescent idiopathic scoliosis
  5 reports
• EXPEDIUM SFX 189401209

  Orthosis, spondylolisthesis spinal fixation
  3 reports
• EXPEDIUM SFX 289410400

  CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
  3 reports
• EXPEDIUM SFX 189401302

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  2 reports
• EXPEDIUM SFX 189401102

  Orthosis, spondylolisthesis spinal fixation
  1 report
• EXPEDIUM SFX 189401105

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  1 report
• EXPEDIUM SFX 189401206

  ORTHOSIS, SPINAL PEDICLE FIXATION
  1 report
• EXPEDIUM SFX 189401407

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  1 report
• EXPEDIUM SFX 189403211

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  1 report

Recent EXPEDIUM SFX adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2026Break

  IT WAS REPORTED THE DRILL BITS BROKE IN TWO PIECES DURING AN UNKNOWN PROCEDURE. ANOTHER SET WAS OPENED. NO PATIENT CONSEQUENCES. A SURGICAL DELAY OF 3 MINUTES WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25639860 ↗
• MalfunctionJun 26, 2026Break

  IT WAS REPORTED THE DRILL BITS BROKE IN TWO PIECES DURING AN UNKNOWN PROCEDURE. ANOTHER SET WAS OPENED. NO PATIENT CONSEQUENCES. A SURGICAL DELAY OF 3 MINUTES WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25639723 ↗
• MalfunctionJun 26, 2026Break

  IT WAS REPORTED THE DRILL BITS BROKE IN TWO PIECES DURING AN UNKNOWN PROCEDURE. ANOTHER SET WAS OPENED. NO PATIENT CONSEQUENCES. A SURGICAL DELAY OF 3 MINUTES WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25639554 ↗
• MalfunctionJun 26, 2026Break

  IT WAS REPORTED WHILE TIGHTENING THE FINAL SCREW, THE TIP OF THE SCREWDRIVER BROKE. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25638706 ↗
• MalfunctionApr 8, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE FINAL TIGHTENER WAS BENT AND DID NOT ENGAGE ON THE SET SCREW. AN ALTERNATIVE DEVICE WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816825 ↗
• MalfunctionFeb 12, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS A SPINAL FUSION PERFORMED ON (B)(6) 2026. AFTER DETERMINING THE SIZE OF THE CONNECTOR AND THE SURGEON TRIED TO INSTALL IT ON THE ROD, THE SURGEON POINTED OUT THAT IT "DOESN'T FIT PROPERLY ON THE ROD." CONSIDERING THE POSSIBILITY THAT THE SET SCREW HAD NOT BEEN LOOSENED SUFFICIENTLY, THE SURGEON RETURNED IT TO A STABLE TABLE AND USED A SCREWDRIVER TO CHECK THAT IT WAS LOOSE AGAIN BEFORE INSTALLING IT ON THE ROD. AFTER DETERMINING THE POSITION AND ATTEMPTING TO TIGHTEN IT WITH THE SCREWDRIVER, THE SURGEON POINTED OUT THAT "THE SET SCREW MAY BE LOOSE." THE SURGEON CHANGED THE SCREWDRIVER AND LIGHTLY TIGHTENED IT AGAIN, BUT IT STILL FELT LOOSE. BECAUSE THERE WAS A RISK THAT THE IMPLANT WOULD BE DIFFICULT TO REMOVE, THE SALES REPRESENTATIVE REQUESTED AN EXCHANGE AND USED A DIFFERENT PRODUCT, WHICH ALLOWED THE OPERATION TO BE COMPLETED WITHOUT ANY PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327540 ↗
• MalfunctionJan 16, 2026Calibration Problem

  IT WAS REPORTED THAT THE DEVICE FAILED THE TORQUE TEST WITH READING 6.2-6.4. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24095776 ↗
• MalfunctionDec 2, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE DEVICE DID NOT MEET SPECIFICATIONS FOR TORQUE TESTING. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696432 ↗
• MalfunctionNov 26, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THIS WAS A PLIF PERFORMED ON (B)(6) 2025. AT THE END OF THE PROCEDURE, WHILE PERFORMING THE FINAL TIGHTENING CROSSLINK WITH THE SCREWDRIVER, THE TORQUE WAS NOT APPLIED PROPERLY AND THE SCREWDRIVER SLIPPED SEVERAL TIMES. SINCE THERE WAS ANOTHER IDENTICAL SCREWDRIVER TIP AVAILABLE, THE SURGEON SWITCHED TO THAT AND WERE ABLE TO USE IT PROPERLY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE SURGERY, THE SALES REP CHECKED THE TIP OF THE SCREWDRIVER AND CONFIRMED THAT IT HAD BEEN DEFORMED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658719 ↗
• MalfunctionSep 16, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING THE SURGERY, THE CONNECTOR COULDN'T BE INSTALLED AS IT WAS, SO AFTER BENDING IT AND INSTALLING IT AGAIN SEVERAL TIMES, THE THREADS ON THE SET SCREW BROKE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINS OF DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062806 ↗
• MalfunctionSep 9, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT PATIENT UNDERWENT A SPINAL FUSION FOR A VERTEBRAL BURST FRACTURE ON (B)(6) 2025. USING THE SFX, THE SURGEON ATTEMPTED FINAL TIGHTENING ACCORDING TO THE PROCEDURE MANUAL, BUT THE DEVICE STRIPPED, AND THE SURGEON WAS UNABLE TO COMPLETE THE FINAL TIGHTENING OF THE SCREW. THE HOSPITAL HAD ANOTHER PRODUCT OF THE SAME SPECIFICATIONS AS THE SFX IN QUESTION, SO THE SURGEON USED THAT AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE SURGEON HAVE EXPERIENCED A SIMILAR PHENOMENON WITH THE SFX IN THE PAST, SO THEY PERFORMED THE FINAL TIGHTENING OPERATION WITH GREAT CARE, BUT THIS TIME, THE BEING STRIPPED OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23008543 ↗
• MalfunctionJul 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT 2 DRIVERS FROM THE EXPEDIUM 4.5 LENGTHENING SET WITH THE DUAL CHAMBER CONNECTER WERE STRIPPED. OTHER AVAILABLE DEVICES WERE USED IN ORDER TO COMPLETE THE PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22439909 ↗
• MalfunctionJul 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT 2 DRIVERS FROM THE EXPEDIUM 4.5 LENGTHENING SET WITH THE DUAL CHAMBER CONNECTER WERE STRIPPED. OTHER AVAILABLE DEVICES WERE USED IN ORDER TO COMPLETE THE PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22439865 ↗
• MalfunctionJun 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE SURGEON WAS PERFORMING A LENGTHENING OF 4.5 EXPEDIUM AS WELL AS PROXIMAL AND DISTAL ANCHORS WITH EXPEDIUM 5.5 ON (B)(6) 2025. IN THE PROCESS, THE SURGEON STRIPPED THE SHAFT FOR THE FINAL TIGHTENING OF THE CONNECTORS FOR THE 4.5 AND STRIPPED 4 TORQUE DRIVES AS WELL. NO DELAYS WERE OBTAINED; SPARES WERE READILY AVAILABLE. NO IMPACT TO THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195840 ↗
• InjuryJun 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023 THE PATIENT HAD FUSION SURGERY AT T12-L1 AND A DEPUY EXPEDIUM WAS THE HARDWARE USED IN HER BACK. ON (B)(6) 2024 HER PROVIDERS REALIZED THAT THE HARDWARE HAD FAILED DUE TO "STRIPPED SCREWS" AND REVISION OF THE SURGERY HAD TO BE DONE TO T12-L1 AND TO THE NEXT LEVEL UP WHICH IS THE L1-L2, CAUSING SERIOUS INJURIES TO PATIENT. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22194703 ↗

Other Depuy Spine, LLC products

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• MOSS16 models · 787 reports
• EXPEDIUM29 models · 189 reports
• EXPEDIUM VIPER5 models · 103 reports
• UNIPLATE6 models · 56 reports
• ISOLA8 models · 43 reports
• EXPEDIUM TOP NOTCH2 models · 42 reports
• MOUNTAINEER5 models · 40 reports