EXPEDIUM 179712980Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034068312), received between Apr 2, 2018 and Jul 1, 2024 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

8 other recalls cover devices cleared under the same FDA submission (K101993); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SCREWDRIVER T20 TIP SNAPPED OFF INSIDE THE SCREW. THIS CAUSED ISSUES REMOVING THE SCREW AS THE SCREW WAS NOT FULLY INSERTED. THE POLYAXIAL HEAD THEN POPPED OFF WHEN TRYING TO REMOVE THE SCREW AND THE SCREW WAS REMOVED BY A MOLE GRIP WRENCH. ANOTHER SCREW WAS INSERTED AND THE SURGERY WAS COMPLETED. SURGERY WAS EXTENDED BY 25-30MINUTES WHILE TRYING VARIOUS WAYS TO REMOVE THE SCREW FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO INJURY TO THE PATIENT. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 X 9 X 80MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643937 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  B5 (EVENT DESCRIPTION): DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: NON-UNION, SPINAL IMBALANCE, COMPLICATION TIME/INTERVENTION. REPEAT SURGERY , THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 X 9 X 80MM. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: Joint Laxity; Nonunion/Delayed-union Bone Fracture

  MAUDE report 18452689 ↗
• MalfunctionAug 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN SPAIN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE TULIP OF THE ILIAC SCREW HAS BEEN DISASSEMBLED WHEN IMPLANTING IT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FRAGMENTS GENERATED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 X 9 X 80MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435588 ↗
• InjuryDec 1, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE ROD CAME OUT OF PELVIC SCREW. PATIENT CONSEQUENCE? YES. PATIENT CONSEQUENCE DESCRIPTION: REVISION SURGERY. ACTION TAKEN FOR PROCEDURE: NEW ROD. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Code Available

  MAUDE report 8121825 ↗
• InjuryJun 14, 2018Break; Break

  DURING A REVISON THE SURGEON TOOK OUT A SCREWS FROM THE PATIENT. A SCREW HAD SOME CHANGES IN THE TIP. PATIENT CONSEQUENCE? NO. ACTION TAKEN FOR PROCEDURE: JUST LIKE PLANNED, NEW SCREW.

  Patient problems: No Consequences Or Impact To Patient; Spinal Column Injury

  MAUDE report 7601177 ↗
• InjuryApr 2, 2018Break; Break

  THIS WAS A T10-PELVIS REVISION SPINE SURGERY WHERE THE PATIENT HAD AN EXPEDIUM 8X80 SI SCREW AT S2. THE SURGEON TOOK OUT THE EXISTING 8X80 SCREW AND REVISED WITH NEW LARGER DIAMETER EXPEDIUM 9X80 SCREW. DURING INSERTION OF THE 9X80 SCREW THE TIP OF THE SI POLYAXIAL DRIVER (2797-12-400) BROKE OFF INTO THE SCREW/DRIVER INTERFACE. WITH NO DRIVER TO ENGAGE THE SCREW THE SURGEON ATTEMPTED TO INSERT THE SCREW FURTHER UTILIZING AN INSTRUMENT THAT GOES OVER THE HEAD OF THE SCREW AND HAS A BUILT IN ROD TO ENGAGE THE POLYAXIAL HEAD. HE THEN PLACED A SET SCREW THROUGH THE CANNULA OF THE INSTRUMENT TO LOCK THE INSTRUMENT TO THE SCREW ALLOWING HIM TO ADVANCE THE SCREW. DURING THIS ADVANCEMENT THE HEAD OF THE 9X80 SCREW BROKE OFF. THE SURGEON ENDED UP LEAVING THE BROKEN SCREW IN THE PATIENT. ADDITIONAL INFORMATION FROM SALES REP: THE REASON FOR THE REVISION WAS THE PT HAD SOME INFECTION GOING ON AND THE SURGEON WANTED TO WASH OUT THE WOUND, SEND CULTURES FOR LAB TESTING AND REPLACE ALL SCREWS. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Injury; Local Reaction; Not Applicable

  MAUDE report 7389300 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101993. One submission often covers many models, so check the product and lot details in each record.

• Z-0705-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component.
• Z-0708-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Component.
• Z-0706-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component.
• Z-0713-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component.
• Z-0712-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.
• Z-0707-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant Component.
• Z-0710-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Component.
• Z-0709-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant Component.