EXPEDIUM 179712199Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034066899), received between Feb 18, 2022 and Jun 20, 2023 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 20, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREW BROKE AT THE SHAFT DURING INSERTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FRAGMENTS WERE GENERATED, AND THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 X 10 X 100MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17161490 ↗
• MalfunctionFeb 18, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A PELVIC SURGERY ON THE RIGHT SIDE, THE SURGEON PREPPED THE PELVIS FOR SCREW INSERTION. THE SURGEON USED A PEDICLE FINDER TO CREATE A TRACK AND THEN TAPPED THE INTENDED SCREW HOLE. A SCREW WAS SELECTED AND LOADED ONTO THE SCREWDRIVER. THE SCREW WAS INSERTED UNDER NORMAL FORCE. AN X-RAY WAS TAKEN AND AT THIS POINT THE SEMI INSERTED SCREW WAS DISENGAGED FROM THE SCREWDRIVER. X-RAY WAS TAKEN AND THEN THE SCREWDRIVER WAS REATTACHED. THE SURGEON THEN BEGAN TO STRUGGLE TO ADVANCE THE SCREW AND SIGNIFICANTLY MORE FORCE WAS REQUIRED. THE SCREW STOPPED ADVANCING, THE DRIVER WAS DISENGAGED, IT WAS NOTED THAT THE DISTAL END OF THE SCREWDRIVER HAD BROKEN OFF INSIDE THE SCREW SHAFT THUS PREVENTING ADVANCEMENT. IT WAS DECIDED TO PLACE A ROD IN THE SCREWHEAD, LOCK THE ROD DOWN WITH A SET SCREW AND ¿HELICOPTER¿ THE SCREW OUT. THIS UNFORTUNATELY LED TO THE TULIP SHEARING OFF THE SCREW SHAFT. THE BROKEN SCREW SHAFT WAS NOW STUCK IN THE PELVIS AND HAD TO BE BURRED OUT. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE SCREW WITH A SCREW REMOVAL KIT AND OTHER INSTRUMENTATION. ON LEFT SIDE OF THE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559382 ↗

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-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-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-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-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-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-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.