EXPEDIUM 179712855Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034068091), received between Nov 27, 2019 and Jan 4, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Entrapment of Device” (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. 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.

• InjuryJan 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: ADJACENT SEGMENT PATHOLOGY, IMPLANT FAILURE. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER AND EXPEDIUM POLYAXIAL PRODUCTS (EXP TI POLY SCREW 8MMX55MM FOR (B)(4).

  Patient problems: Insufficient Information; Osteolysis

  MAUDE report 18443065 ↗
• InjuryNov 27, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING POSTERIOR SPINAL FUSION, THE SURGEON REMOVED THE "VERSE" HARDWARE AND REPLACED IT WITH DEPUY SYNTHES SPINE EXPEDIUM. DURING THE REPLACEMENT OF THE LEFT L2 SCREW, HE BROKE OFF THE TIP OF THE EXPEDIUM DRIVER WHILE INSERTING A 8.0 X 55 MM EXPEDIUM SCREWS. THE DIAMETER OF THE VERSE SCREW WAS A 7.0MM SCREW. THE SURGEON DID NOT TAP PRIOR TO PLACING THE 8.0MM SCREW. THERE WAS A TREMENDOUS AMOUNT OF TORQUE DURING PLACEMENT OF THE SCREW. BEFORE THE SCREW WAS FULLY SEATED, THE SCREWDRIVER TIP BROKE OFF. THE SURGEON ATTEMPTED TO REMOVED THAT SCREW, BUT WAS NOT SUCCESSFUL. HE ENDED UP CUTTING THE HEAD OFF WITH A METAL CUTTING BURR, AND TRIED TO GET OUT THE SCREW SHAFT WITH A VICE GRIP AND USS ROD HOLDER, BUT THE SCREW WOULD NOT MOVE. HE DECIDED THAT IT WAS BEST TO LEAVE THE SCREW. HE ENDED UP REPLACING ALL THE OTHER SCREWS FROM L1-L4 SUCCESSFULLY WITH THE EXCEPTION OF THAT LEFT L2 SCREW. HE THEN PLACED NEW SCREWS AT THE L5 AND S1 LEVELS. HE THEN BURRED DOWN THE BROKEN SCREW SHAFT AT L2 SO THE ROD WOULD FIT ABOVE THE SCREW SHAFT. TO DO THIS HE USED A METAL CUTTING BURR AND STERILE ULTRASOUND GEL TO CAPTURE THE FRAGMENTS AND THEN SUCK THEM UP WITH SUCT

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9383749 ↗

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-0713-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 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.
• 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-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-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-0705-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component.