EXPEDIUM 179712870Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034068121), received between Apr 8, 2021 and Apr 8, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT SURGERY ON (B)(6) 2021. DURING SURGERY, TWO PELVIC SCREWS WERE PLANNED TO BE INSERTED BUT DOCTOR HAD ISSUES WITH BOTH. ONE SCREW HEAD BROKE, AND THE DOCTOR COULD NOT REMOVE THE SCREW FROM THE PELVIS BUT WAS ABLE TO REMOVE THE OTHER ONE. THE REMOVED SCREW WAS DISCARDED. NEW SCREWS WERE IMPLANTED. CHECKING THE OR IMAGES CONFIRMED THAT AN EXPEDIUM PELVIC SCREW WITH BROKEN SCREW HEAD WAS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THIRTY TO FORTY-FIVE (30-45) MINUTE DELAY. THIS REPORT IS FOR AN EXPEDIUM TITANIUM (TI) POLY SCREW 8MMX70MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633704 ↗
• MalfunctionApr 8, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT SURGERY ON (B)(6) 2021. DURING SURGERY, TWO PELVIC SCREWS WERE PLANNED TO BE INSERTED BUT DOCTOR HAD ISSUES WITH BOTH. ONE SCREW HEAD BROKE, AND THE DOCTOR COULD NOT REMOVE THE SCREW FROM THE PELVIS BUT WAS ABLE TO REMOVE THE OTHER ONE. THE REMOVED SCREW WAS DISCARDED. NEW SCREWS WERE IMPLANTED. CHECKING THE OR IMAGES CONFIRMED THAT AN EXPEDIUM PELVIC SCREW WITH BROKEN SCREW HEAD WAS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THIRTY TO FORTY-FIVE (30-45) MINUTE DELAY. THIS REPORT IS FOR AN EXPEDIUM TITANIUM (TI) POLY SCREW 8MMX70MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633651 ↗

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-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-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-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-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-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-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.