EXPEDIUM 179712945Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034068244), received between Jun 7, 2018 and Jun 7, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionJun 7, 2018Break; Break

  IT WAS REPORTED THAT AFTER REMOVAL OF HARDWARE, DR. (B)(6) ATTEMPTED TO REPLACE A MONARCH BOLT 8.5X15 WITH AN EXPEDIUM 9X45 (1796-12-945) POLY SCREW. HE DID NOT TAP AS HE DID NOT BELIEVE IT WAS NECESSARY. DURING INSERTION, HE ENCOUNTERED GREAT RESISTANCE AND THE INNER DRIVER OF THE INSERTER BROKE OFF IN THE POLY-SCREW. HE THEN PUT A ROD IN THE SCREW AND ATTEMPTED TO HELICOPTER THE SCREW OUT, WHICH FAILED AS THE POLY HEAD CAME APART UNDER THE STRESS. IT WAS DETERMINED THAT LEAVING THE REMAINDER OF THE SCREW WAS BEST AND THE REMAINDER OF THE CASE WENT OFF WITHOUT INCIDENT. ATTRIBUTABLE CAUSE OF THE FAILURE WAS DOCUMENTED BY THE SALES REP AS: PRIOR SURGERY, VERY HARD BONE, AND REVISION OF A VERY LARGE SCREW(AN 8.5MM MONARCH BOLT WITH A 9MM EXPEDIUM POLY SCREW.) THE SURGERY WAS PROLONGED LESS THAN 30 MINUTES. NO PATIENT ADVERSE CONSEQUENCE.

  Patient problems: Not Applicable

  MAUDE report 7579813 ↗

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-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-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-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-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-0708-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Component.