EXPEDIUM 179712880Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034068145), received between Feb 27, 2018 and Aug 15, 2024 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2024Break; Break

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2024, THE T20 SCREWDRIVER TIP SNAPPED OFF INSIDE THE SCREW. THIS CAUSED ISSUES REMOVING THE SCREW AS THE SCREW WAS NOT FULLY INSERTED. THE POLYAXIAL HEAD THEN POPPED OFF WHEN TRYING TO REMOVE THE SCREW, AND THE SCREW WAS REMOVED BY A MOLE GRIP WRENCH. ANOTHER SCREW WAS INSERTED, AND THE SURGERY WAS COMPLETED. THE SURGERY WAS EXTENDED BY APPROXIMATELY 60 MINUTES WHILE TRYING VARIOUS WAYS TO REMOVE THE SCREW FROM THE PATIENT. THE OPERATION WAS REQUIRED TO BE COMPLETED USING ALTERNATIVE METHODS. THERE WAS NO INJURY TO THE PATIENT. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 X 8 X 80MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19996674 ↗
• InjuryJan 5, 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: WOUND HEALING PROBLEM, COMPLICATION TIME/INTERVENTION, REPEAT SURGERY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 X 8 X 80MM. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 18452396 ↗
• MalfunctionNov 15, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE WHILE PLACING A LEFT SIDED S2AI SCREW, THE TIP OF 5.5 NAV DRIVER - SHAFT T20 SHEARED OFF INSIDE THE DRIVE RECESS OF THE SCREW. AS THIS WAS A REVISION SURGERY, THIS SCREW WAS ALREADY IMPLANTED PREVIOUSLY AND THE SURGEON WAS REPLACING IT IN A NEW TRAJECTORY. AFTER THE DRIVER BROKE, THE SCREW WAS SUCCESSFULLY REMOVED AND A NEW SCREW WAS IMPLANTED. THE HOSPITAL DISCARDED THE SCREW WITH THE BROKEN DRIVER TIP. THE SURGEON¿S COMPLAINT IS THE TIP OF AN EXPEDIUM 5.5 SCREWDRIVER (T20) IS TOO SMALL/WEAK WHEN INSERTING LARGER DIAMETER SCREWS, SPECIFICALLY IN REVISION SURGERIES SUCH AS THIS WHEN THE BONE IS SCLEROTIC. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) EXP TI POLY SCREW 8MMX80MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12816703 ↗
• InjuryFeb 11, 2021Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A REVISION SPINAL SURGERY WAS PERFORMED FOR A PATIENT WITH PLASMOCYTOMA. THE SACROILIACAL SCREWS WERE LOOSENED, AND ONE DISCONNECTED FROM THE ROD. BOTH SCREWS WERE REPLACED WITH LARGER DIAMETER SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 X 8 X 80MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11313216 ↗
• InjuryFeb 11, 2021Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A REVISION SPINAL SURGERY WAS PERFORMED FOR A PATIENT WITH PLASMOCYTOMA. THE SACROILIACAL SCREWS WERE LOOSENED, AND ONE DISCONNECTED FROM THE ROD. BOTH SCREWS WERE REPLACED WITH LARGER DIAMETER SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 X 8 X 80MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11313214 ↗
• MalfunctionJul 17, 2018Break; Break

  THE ILLEUM SCREW INNER PART BROKE AND ALSO THE K WIRE UNFORTUNATELY BROKE. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7694339 ↗
• MalfunctionMar 29, 2018Break; Break

  ILIAC SCREW WAS BEING INSERTED UNDER THE EXPEDIUM POWER SET. THE EXPEDIUM POWER DRIVER SHAFT BROKE IN THE PROCESS, ALONG WITH THE HEAD OF THE ILIAC SCREW. PATIENT CONSEQUENCE? :NO ACTION TAKEN FOR PROCEDURE:SCREW WAS REMOVED AND WE GRABBED OUR BACKUP EXPEDIUM DRIVER TO CONTINUE THE PROCEDURE. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7382111 ↗
• InjuryFeb 27, 2018Break; Break

  PT HAD ORIGINAL SURGERY 2 YEARS AGO. ONE YEAR AGO FOR POST OP X-RAYS, THE BROKEN SCREW WAS IDENTIFIED. THE REVISION SURGERY TO REMOVE THE SCREW WAS THEN DONE ON (B)(6) 2018. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Not Applicable; Spinal Column Injury

  MAUDE report 7300809 ↗

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-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-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-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-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-0706-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component.