EXPEDIUM 179712835Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034068053), received between May 31, 2018 and May 31, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2018Break; Break

  PT SCHEDULED FOR REVISION L5-S1 FUSION. PT PRESENTED WITH BILATERAL S1 BROKEN SCREWS (7.0 X 35MM EXPEDIUM POLYS). EXISTING HARDWARE AT S1 WAS REMOVED USING TREPHINES AND SCREW EXTRACTORS. S1 SCREWS WERE REPLACED WITH 8.0 X 35MM POLYS. THE LEFT S1 SCREW WAS INSERTED UNTIL THE DISTAL TIP REACHED THE CONTRALATERAL CORTEX OF THE SACRUM. SURGEON FELT SCREW WAS TOO PROUD AND ATTEMPTED TO ADVANCE THE SCREW SHEARING OF THE TIP OF THE EXPEDIUM QUICK CONNECT POLY DRIVER INTO THE SHANK OF THE SCREW. SURGEON TRIED TO ADVANCE BY LOCKING ROD INTO SCREW AND TURNING WITH COUNTERTORQUE WITH NO RESULTS. SURGEON REMOVED SCREW HEAD WITH DIAMOND BUR AND ATTEMPTED TO REMOVE SHANK WITH SCREW EXTRACTOR, NO RESULTS. SURGEONS ABANDONED THE SCREW REMOVAL AND COMPLETED THE CONSTRUCT FROM L4-ILEUM. NO FURTHER ISSUES. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7558164 ↗

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-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-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.
• 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-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-0713-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 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-0710-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Component.