EXPEDIUM VERSE 199723650SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034443522), received between Apr 20, 2019 and Jan 8, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Break” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  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: IMPLANT FAILURE COMPLICATION TIME/INTERVENTION. REPEAT SURGERY THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 6.0 X 50MM THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18466236 ↗
• 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: NON-UNION; COMPLICATION TIME/INTERVENTION; REPEAT SURGERY; THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 6.0 X 50MM; THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18462987 ↗
• InjuryJan 5, 2024Migration; Migration

  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: IMPLANT MALPOSITION, COMPLICATION TIME/INTERVENTION, AND REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER, EXPEDIUM VERSE FENESTRATED AND MOSS MIAMI SI /OTHER PRODUCTS. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18455581 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: NON-UNION, COMPLICATION TIME/INTERVENTION, REPEAT SURGERY, THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X50. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18454949 ↗
• 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: NEUROCOMPRESSION. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 6.0 X 50MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Nerve Damage

  MAUDE report 18453861 ↗
• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A SPINAL FUSION(T10) FOR TREATING DEGENERATIVE DISEASE ON (B)(6) 2022. TWO SCREWS WERE APPLIED TO LESION. THEN, THE PATIENT'S BLOOD PRESSURE DECREASED DURING SURGERY. THE SURGEON FINISHED THE OPERATION IMMEDIATELY. NO SURGICAL DELAY WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 6.0 X 50MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 15453848 ↗
• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A SPINAL FUSION(T10) FOR TREATING DEGENERATIVE DISEASE ON (B)(6) 2022. TWO SCREWS WERE APPLIED TO LESION. THEN, THE PATIENT'S BLOOD PRESSURE DECREASED DURING SURGERY. THE SURGEON FINISHED THE OPERATION IMMEDIATELY. NO SURGICAL DELAY WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 6.0 X 50MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 15453826 ↗
• InjuryDec 14, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2021 WITH THE IMPLANTS IN QUESTION TREATING DORSAL SPONDYLODESIS L5/ S1. ON AN UNKNOWN DATE, TWO (2) EXPEDIUM SCREWS BROKE IN THE PATIENT. THE SCREWS WERE REMOVED FROM THE PATIENT ON (B)(6) 2021 AND THE PATIENT RECEIVED A NEW FIXATEUR INTERN. THE PATIENT OUTCOME WAS REPORTED AS GOOD. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 6.0 X 50MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

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

  MAUDE report 13003292 ↗
• InjuryApr 20, 2019Break; Break

  IT WAS REPORTED THAT THE SURGEON PERFORMED A SINGLE LEVEL FUSION AT L5S1 6 MONTHS PREVIOUSLY USING EXPEDIUM VERSE ADVANCED IMPLANTS. AT THE 6 MONTH FOLLOW UP THE SURGEON TOOK X RAYS AND NOTED BOTH THE TIPS OF THE 6.0 X 50 MM S1 SCREWS HAD BROKEN. THE PATIENT IS NOW EXPERIENCING BACK PAIN AND WE ARE LOOKING TO REVISE THE CASE IN THE FUTURE.

  Patient problems: No Code Available; Pain

  MAUDE report 8534172 ↗
• InjuryApr 20, 2019Break; Break

  IT WAS REPORTED THAT THE SURGEON PERFORMED A SINGLE LEVEL FUSION AT L5S1 6 MONTHS PREVIOUSLY USING EXPEDIUM VERSE ADVANCED IMPLANTS. AT THE 6 MONTH FOLLOW UP THE SURGEON TOOK X RAYS AND NOTED BOTH THE TIPS OF THE 6.0 X 50 MM S1 SCREWS HAD BROKEN. THE PATIENT IS NOW EXPERIENCING BACK PAIN AND WE ARE LOOKING TO REVISE THE CASE IN THE FUTURE.

  Patient problems: No Code Available; Pain

  MAUDE report 8534171 ↗