EXPEDIUM VERSE 199723545SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034443324), received between Nov 10, 2020 and Nov 21, 2025 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Break; Break

  IT WAS REPORTED THE VERSES CORRECTION KEYS AND A SCREW BROKE DURING FINAL TIGHTENING. THE PROCEDURE WAS COMPLETED WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619029 ↗
• InjuryAug 20, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR FUSION (TH11-L1) FOR BURST FRACTURE ON (B)(6) 2023. THE SURGERY WAS COMPLETED SUCCESSFULLY NO WITH SURGICAL DELAY. ON JULY 23, 2024, WHEN CONFIRMING THE SURGERY SCHEDULED FOR (B)(6) 2024 THE BREAKAGE OF THE SCREW IN QUESTION WAS DISCOVERED. THE BREAKAGE SITE IS ON EITHER SIDE OF L1 OF TH11-L1 FIXATION, AND THE BROKEN PART OF THE SCREW IS AT THE SIDE HOLE OF THE FENESTRATED SCREW. ON THE 24TH SURGERY, THE UPPER PART OF THE BROKEN SCREW WILL BE REMOVED, AND THE REMAINING PART OF THE SCREW WILL LEFT IN THE VERTEBRAL BODY AS IT WAS PROBABLY NOT REMOVABLE. THE SURGEON COMMENTED THE SECOND SURGERY DUE TO THE SCREW BREAKAGE. ONE POSSIBLE CAUSE, OTHER THAN PRODUCT, IS THE IDEA THAT THE SCREW MAY HAVE BEEN OVERLOADED, LEADING TO FRACTURE, BECAUSE THE ANTERIOR PROP RECONSTRUCTION WAS NOT PERFORMED AND THE PROCEDURE WAS PERFORMED POSTERIORLY ALONE. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES ONE (1) EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.0 X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 20000657 ↗
• InjuryDec 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT PLF (L2) FOR LUMBAR SPINAL CANAL STENOSIS ON (B)(6) 2022. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. ON (B)(6) 2022, THE SURGEON REPORTED THAT THE VERTEBRAL BODY (L2) IN WHICH THE SCREW HAD BEEN INSERTED WAS FRACTURED. 1.0CC OF CEMENT HAD BEEN INJECTED ON EACH SIDE. THE PATIENT COMPLAINED OF PAIN, SO THE SURGEON CONSIDERS A REVISION SURGERY IF BONE UNION WILL NOT BE ACHIEVED. THE SURGEON IS UNSURE WHETHER THE EVENT IS RELATED TO THE CEMENT OR HAPPENED DUE TO POOR BONE QUALITY. (B)(4) ARE INVOLVED WITH THE SAME EVENT. (B)(4) (DEPUY SPINE): REPORTS THE SCREW. (B)(4) (SYNTHES SPINE): REPORTS THE CEMENT. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.0 X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 16003108 ↗
• InjuryNov 14, 2022Difficult to Advance; Difficult to Advance

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED WITH THE SCREWS AND THE CEMENT ON (B)(6) 2022. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THERE WAS A POSSIBILITY THAT THE CEMENT LEAKED. THE SIZE OF THE SCREW MIGHT BE TOO SHORT. ON (B)(6) 2022, A REVISION SURGERY WILL BE PERFORMED. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 5.0X45. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15793407 ↗
• InjuryNov 14, 2022Difficult to Advance; Difficult to Advance

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED WITH THE SCREWS AND THE CEMENT ON (B)(6) 2022. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THERE WAS A POSSIBILITY THAT THE CEMENT LEAKED. THE SIZE OF THE SCREW MIGHT BE TOO SHORT. ON (B)(6) 2022, A REVISION SURGERY WILL BE PERFORMED. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 5.0X45. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15793150 ↗
• InjuryApr 26, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT IN A POST-SURGERY MRI, THAT THE EXPEDIUM VERSE SCREW WAS BROKEN IN THE TIP. THE TIP IS LOCATED INSIDE THE VERTEBRAL BODY, CURRENTLY WITHOUT PROBLEMS FOR THE PATIENT. THE PATIENT WAS INITIALLY TREATED FOR ADOLESCENT IDIOPATHIC SCOLIOSIS - DEFORMITY. THERE IS NO PLAN FOR REVISION SURGERY. THIS REPORT IS FOR A 5.5 EXPEDIUM VERSE FENESTRATED SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 11725486 ↗
• MalfunctionNov 10, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 WHILE INSERTING THE NUT, JUST PAST THE WING OF THE VERSE SCREW, THE NUT BEGAN TO FILLET. ANOTHER NUT WAS TRIED WITHOUT SUCCESS. THIS HAPPENED ON THREE (3) SCREWS WHICH HAD TO BE REPLACED. ONE OF THE SCREWS WAS INSERTED WITH A LARGER DIAMETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 120 MINUTE DELAY. THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.0 X 45MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10817617 ↗