EXPEDIUM 179712890Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034068169), received between Nov 2, 2020 and Nov 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.

• InjuryNov 2, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT HAD HARDWARE FROM T5-ILIUM. THERE WAS NO SCREW IN L1 AND AN EXTENSION CONNECTOR CONNECTING THE UPPER AND LOWER ROD. THE SURGEON THOUGHT THAT THE PREVIOUS SURGERY WAS ON AN UNKNOWN DAY IN (B)(6) 2019. THE SURGEON SAID THAT THE PATIENT HAS A NON UNION AT L5-S1. AT AN UNKNOWN POINT IN TIME THE PATIENT BROKE THE FOLLOWING HARDWARE: LEFT ILIAC SCREW, RIGHT ILIAC SCREW, LEFT S1 SCREW. THESE SCREWS WERE ALL BROKEN RIGHT AT THE BASE OF THE SCREW HEADS. THE SURGEON PERFORMED THE REVISION ON (B)(6) 2020 AND REMOVED THE CAUDAL RODS THAT WERE IN THE EXTENSION CONNECTOR AND THEN REPLACED ALL THE SCREWS FROM L2-ILIUM. THE DEVICES WERE ALL UNKNOWN SIZES EXCEPT THE BROKEN ONES DESCRIBED ABOVE. THE SURGEON WAS ALSO ABLE TO RETRIEVE AND REMOVE THE BROKEN SCREW SHAFTS IN THE ILIAC SCREWS AND LEFT S AND REPLACED ALL THE L2-S1 SCREWS WITH EXPEDIUM SCREWS AND REPLACED THE ILIAC SCREWS WITH VIPER SAI FULLY THREADED SCREWS. THE SURGEON THEN CONTOURED NEW RODS AND PLACED NEW EXTENSION CONNECTORS ON THE CRANIAL ROD AND PLACED AND TIGHTENED THE NEW CAUDAL RODS ONTO THE EXTENSION CONNECTOR AND CONNECTED ALL THE L2-ILIUM SCREWS TO THE NEW EXPEDIUM / SAI SCREWS.

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10773376 ↗

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-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-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-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.
• 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.