EXPEDIUM 179712850Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034068084), received between Jan 28, 2019 and Mar 21, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2024Break; Break

  THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS AND OUTCOME WERE REPORTED AS SURGERY SURGERY FINISHED, SUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 18948468 ↗
• MalfunctionMar 21, 2024Break; Break

  THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS AND OUTCOME WERE REPORTED AS SURGERY FINISHED, SUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 18948467 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: 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: FAILURE TO REACH THERAPEUTIC GOALS, NON-UNION COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 X 8 X 50MM THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information; Nonunion/Delayed-union Bone Fracture

  MAUDE report 18465680 ↗
• InjuryMar 25, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED ON (B)(6) 2022, DURING SPINAL FUSION SURGERY THE TIP OF THE QUICK CONNECT DRIVER BROKE OFF INSIDE AN 8X50MM SCREW WHILE THE SURGEON WAS INSERTING THE SCREW. THE SURGEON REMOVED THE HEAD TO TRY REMOVAL WITH A SRB SET. THE SCREW SHANK WAS UNABLE TO BE EXTRACTED FROM THE PATIENT. FRAGMENTS WERE GENERATED. THERE WAS A SURGICAL DELAY OF FORTY-FIVE (45) MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13902720 ↗
• MalfunctionJan 28, 2019Break; Break

  IT WAS REPORTED THE PATIENT HAS A POSTERIOR SPINE CONSTRUCT FROM T10-ILIUM. THE CONSTRUCT IS TWO CONSTRUCTS ATTACHED WITH CONNECTORS. THE UPPER CONSTRUCT IS T10-L2 SYNTHES USS DUAL OPENING AND IS CONNECTED WITH EXPEDIUM ROD TO ROD CONNECTORS JUST BELOW L2 AND CONNECTS TO A DEPUY EXPEDIUM 5.5MM ROD CONSTRUCT FROM L3-ILIUM. DR. (B)(6) SAID THAT THE LUMBAR PORTION OF THE CONSTRUCT WAS PLACED IN 2015. THE ISSUE IS THAT ACCORDING TO DR. (B)(6) THE PATIENT HAS A NON-UNION AT L5-S1. THE PATIENT'S RODS BROKE BILATERALLY BETWEEN THE L5 AND S1 SCREWS. ON (B)(6) 2019 DR. (B)(6) PERFORMED THE REVISION. DURING THE REVISION, DR. (B)(6) REMOVED THE LEFT AND RIGHT EXPEDIUM RODS THAT WERE CONNECTED TO THE DEPUY ROD TO ROD CONNECTORS. IT APPEARS THAT THE LEFT AND RIGHT RODS WERE CUT FROM A SINGLE 480MM COBALT CHROME ROD - 196789480. THERE WAS NO VISIBLE SERIAL # ON THE RODS. BOTH WERE BROKEN. DR. (B)(6) THEN SWITCH OUT THE RIGHT L5 SCREW THAT WAS LOOSE. HE REMOVED A 7.5MM X 50MM EXPEDIUM POLY SCREW 179712050. HE THEN INSERTED A 8.0 X 50MM (179712850) TO THE SAME SCREW HOLE. THERE WAS A TREMENDOUS AMOUNT OF TORQUE NEEDED TO INSERT THE SCREW. BEFORE GETTING THE SCREW FULLY SEATED, THE DRIVER TIP ON TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8282791 ↗

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-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-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-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-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-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.