EXPEDIUM 179712280Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034067070), received between Jun 2, 2020 and Jun 2, 2020 — classified as 1 injury.

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.

• InjuryJun 2, 2020Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEONS WERE REVISING A PREVIOUS SURGERY THAT HAD DEVELOPED PJK AND SHOWED SIGNS OF ILIAC SCREW FAILURE. THE PATIENT'S INITIAL FUSION (PERFORMED ON (B)(6) 2019) WAS FROM T11-ILIUM, WITH EXPEDIUM 5.5 AND CORTICAL FIX IMPLANTS PLACED FROM T11-L5, AND NUVASIVE RELINE ILIAC BOLTS PLACED FOR THE S2 SAI SCREWS (8.5 X 80MM SCREWS). ON (B)(6) 2020, THE SURGEON REMOVED THE NUVASIVE ILIAC BOLTS (FROM THE PATIENT'S RIGHT SIDE) AND INTENDED TO IMPLANT DSS VIPER SAI ILIAC SCREWS (1797-04-XXX). HE USED A VIPER 9.0 TAP (2797-04-900) AND THE SURGEON PROCEEDED TO PASS A 10MM SAI TAP (2797-04-100) DOWN THROUGH THE PREPARED PATHWAY, AND HE REQUESTED A 11X80MM ILIAC SCREW AND PROCEEDED TO IMPLANT THE 1797-12-280 SCREW. AS THE SCREW ADVANCED THROUGH THE PRIOR PATHWAY, HE FELT THE SCREW WAS NOT ADVANCING THROUGH THE BONE. AT THIS TIME, HE ATTEMPTED TO REMOVE THE ILIAC BOLT FROM THE BONE BUT WAS UNABLE TO ADVANCE THE SCREW IN EITHER DIRECTION (CLOCKWISE OR COUNTERCLOCKWISE). IN THIS PROCESS, THE POLYAXIAL SCREW HEAD BROKE FROM THE ILIAC BOLT AND WAS REMOVED FROM THE PATIENT. ATTEMPTED TO REMOVE THE

  Patient problems: Foreign Body In Patient; Injury; No Code Available

  MAUDE report 10111235 ↗

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-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-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-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-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-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.