EXPEDIUM 179712845Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034068077), received between Dec 21, 2018 and Dec 21, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Disconnection” (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.

• MalfunctionDec 21, 2018Disconnection; Disconnection

  IT WAS REPORTED THAT ACCORDING TO A STATEMENT OF THE USER, THE SCREW WAS ALREADY DAMAGED BEFORE USE. INNER PART OF THE POLYAXIALLY HEAD HAS LOOSEN AND MISPLACED. THUS, THE ROD COULD NOT BE PLACED AT THE SCREW. THE SCREW WAS OUT REVISED AND REPLACED BY A NEW

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8189193 ↗

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-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-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-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-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.
• 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.