EXPEDIUM VERSE 199721650Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034442266), received between Mar 12, 2018 and Jun 15, 2022 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SOUTH KOREA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING THE OPERATION ONE EXPEDIUM VERSE SCREW AND ONE CORRECTION KEY (SET SCREW) WERE BROKEN. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 6.0 X 50MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14703745 ↗
• MalfunctionNov 25, 2020Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2020, A PATIENT WAS TREATED WITH EXP VERSE DUE TO A DEFORMATION OF THE SPINE FROM T4-L4. DURING THE FIRST PART CORRECTION A ROD WAS PLACED AT THE LOWER PART AND THE SCREWS WERE FIXATED WITH A VERSE CORRECTION KEY THROUGH WHICH A MONO-AXIALITY WAS CREATED. THE VERSE CORRECTION KEYS WERE NOT TIGHTENED WITH A TORQUE LIMITED BUT ONLY TIGHTENED SOFTLY BY HAND TO NORMAL SOFTEN TIGHTENING OF THE ROD WITHOUT FINAL LOCKING. AFTER LOOSENING THE VERSE CORRECTION KEYS THE MONO-AXIALITY WAS NOT REVOKED AND THE MONO-BLOCK CONTINUED TO EXIST. NO DE-ROTATION WAS PERFORMED UNTIL THEN. THE L4 EXP VERSE 7MM PEDICLE SCREW BROKE THROUGH AND ALL SCREWS NEEDED TO BE REPLACED WITH BIGGER SCREWS AS THE PEDICLE FRACTURING CAUSED ALL 4 SCREWS BECOME LOCKED MONO-AXIAL CHARACTERISTICS AFTER REMOVING THE TEMPORARY ROD. THERE WAS SURGICAL DELAY OF FORTY (40) MINUTES DUE TO THE REPORTED EVENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE SCREW 6.0 X 50. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10906358 ↗
• MalfunctionNov 25, 2020Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, A PATIENT WAS TREATED WITH EXP VERSE DUE TO A DEFORMATION OF THE SPINE FROM T4-L4. DURING THE FIRST PART CORRECTION A ROD WAS PLACED AT THE LOWER PART AND THE SCREWS WERE FIXATED WITH A VERSE CORRECTION KEY THROUGH WHICH A MONO-AXIALITY WAS CREATED. THE VERSE CORRECTION KEYS WERE NOT TIGHTENED WITH A TORQUE LIMITED BUT ONLY TIGHTENED SOFTLY BY HAND TO NORMAL SOFTEN TIGHTENING OF THE ROD WITHOUT FINAL LOCKING. AFTER LOOSENING THE VERSE CORRECTION KEYS THE MONO-AXIALITY WAS NOT REVOKED AND THE MONO-BLOCK CONTINUED TO EXIST. NO DE-ROTATION WAS PERFORMED UNTIL THEN. THE L4 EXP VERSE 7MM PEDICLE SCREW BROKE THROUGH AND ALL SCREWS NEEDED TO BE REPLACED WITH BIGGER SCREWS AS THE PEDICLE FRACTURING CAUSED ALL 4 SCREWS BECOME LOCKED MONO-AXIAL CHARACTERISTICS AFTER REMOVING THE TEMPORARY ROD. THERE WAS SURGICAL DELAY OF FORTY (40) MINUTES DUE TO THE REPORTED EVENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE SCREW 6.0 X 50. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10906353 ↗
• MalfunctionNov 25, 2020Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, A PATIENT WAS TREATED WITH EXP VERSE DUE TO A DEFORMATION OF THE SPINE FROM T4-L4. DURING THE FIRST PART CORRECTION A ROD WAS PLACED AT THE LOWER PART AND THE SCREWS WERE FIXATED WITH A VERSE CORRECTION KEY THROUGH WHICH A MONO-AXIALITY WAS CREATED. THE VERSE CORRECTION KEYS WERE NOT TIGHTENED WITH A TORQUE LIMITED BUT ONLY TIGHTENED SOFTLY BY HAND TO NORMAL SOFTEN TIGHTENING OF THE ROD WITHOUT FINAL LOCKING. AFTER LOOSENING THE VERSE CORRECTION KEYS THE MONO-AXIALITY WAS NOT REVOKED AND THE MONO-BLOCK CONTINUED TO EXIST. NO DE-ROTATION WAS PERFORMED UNTIL THEN. THE L4 EXP VERSE 7MM PEDICLE SCREW BROKE THROUGH AND ALL SCREWS NEEDED TO BE REPLACED WITH BIGGER SCREWS AS THE PEDICLE FRACTURING CAUSED ALL 4 SCREWS BECOME LOCKED MONO-AXIAL CHARACTERISTICS AFTER REMOVING THE TEMPORARY ROD. THERE WAS SURGICAL DELAY OF FORTY (40) MINUTES DUE TO THE REPORTED EVENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE SCREW 6.0 X 50. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10906270 ↗
• MalfunctionNov 25, 2020Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, A PATIENT WAS TREATED WITH EXP VERSE DUE TO A DEFORMATION OF THE SPINE FROM T4-L4. DURING THE FIRST PART CORRECTION A ROD WAS PLACED AT THE LOWER PART AND THE SCREWS WERE FIXATED WITH A VERSE CORRECTION KEY THROUGH WHICH A MONO-AXIALITY WAS CREATED. THE VERSE CORRECTION KEYS WERE NOT TIGHTENED WITH A TORQUE LIMITED BUT ONLY TIGHTENED SOFTLY BY HAND TO NORMAL SOFTEN TIGHTENING OF THE ROD WITHOUT FINAL LOCKING. AFTER LOOSENING THE VERSE CORRECTION KEYS THE MONO-AXIALITY WAS NOT REVOKED AND THE MONO-BLOCK CONTINUED TO EXIST. NO DE-ROTATION WAS PERFORMED UNTIL THEN. THE L4 EXP VERSE 7MM PEDICLE SCREW BROKE THROUGH AND ALL SCREWS NEEDED TO BE REPLACED WITH BIGGER SCREWS AS THE PEDICLE FRACTURING CAUSED ALL 4 SCREWS BECOME LOCKED MONO-AXIAL CHARACTERISTICS AFTER REMOVING THE TEMPORARY ROD. THERE WAS SURGICAL DELAY OF FORTY (40) MINUTES DUE TO THE REPORTED EVENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE SCREW 6.0 X 50. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10906266 ↗
• InjuryMay 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION AND SEPSIS LEADING TO CAGE BECOMING DISLODGED. SURGEON REMOVED POSTERIOR INSTRUMENTATION, INSERTED ALIF CAGES AND PUT NEW METALWORK IN POSTERIORLY IN THIRD STAGE OPERATION. ALL SCREWS WERE REMOVED, AND BIOPSIES TAKEN OF THE PEDICLES. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 6.0 X 50. THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10038605 ↗
• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 A REVISION SURGERY WAS PERFORMED DUE TO PRIOR SEPSIS. THE L4/S1 METALWORK, L4/5 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) CAGE (CONCORDE CARBON FIBER-REINFORCED POLYMER (CFRP)), DECOMPRESSION AND RE INSTRUMENTED L3 WERE REMOVED. THE PREVIOUS L4-S1 SCREWS WERE REMOVED IN THE FIRST STAGE OF THE OPERATION AND THE EXPEDIUM VERSE SCREWS WERE IMPLANTED AT L3 WITH THE TABS. AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) WAS COMPLETED ON (B)(6) 2020, FOLLOWED BY COMPLETION OF POSTERIOR INSTRUMENTATION ON (B)(6) 2020. THE SCREW WAS NOT EXPLANTED ON (B)(6) 2020. THE SURGEON NEEDED TO EXTEND THE FUSION SO THE SCREWS WERE INSERTED DURING THE FIRST STAGE ON (B)(6) 2020 AND THEN THE REMAINING SCREWS WERE IMPLANTED ON (B)(6) 2020 AND CONNECTED THE FINAL CONSTRUCT, ALL TABS WERE REMOVED AT THIS STAGE. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE SCREW 6.0 X 50. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9792115 ↗
• InjuryApr 26, 2018Material Deformation; Torn Material; Material Deformation; Torn Material

  (B)(6); BIG HEADS LEIGH AFTER SPONDY REDUCTION. LOCKING CAP CAME OUT BY USING THE TORQUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7466143 ↗
• InjuryMar 14, 2018Break; Break

  PATIENT WAS SCHEDULED TO HAVE A HARDWARE REMOVAL DUE TO INFECTION. PREVIOUS CONSTRUCT WAS T3-L3, DEPUY SYNTHES SPINE VERSE PRODUCT WAS USED. L3 LEVEL OF THE CONSTRUCT, SHAFT OF THE SCREW WAS BROKE ON THE RIGHT SIDE, L3 LEFT PEDICLE SCREW, TULIP WAS COMPLETELY SEPARATED FROM THE SHAFT OF THE SCREW. ALL OF THE UNITIZED SET SCREWS PRODUCT CODE 199721001 WE LOOSE AND ALMOST DISENGAGING FROM THE TULIP. ALL OF THE UNITIZED SET SCREWS WERE VERY LOOSE. PATIENT CONSEQUENCE?: YES. PATIENT CONSEQUENCE DESCRIPTION:PATIENT HAD REVISION OF PREVIOUS SPINAL FUSION WHERE ALL OF THE HARDWARE WAS REMOVED. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES. SEE RELATED INCIDENT (B)(4) FOR REMAINING PRODUCTS.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7337681 ↗
• InjuryMar 12, 2018Break; Break

  PATIENT WAS SCHEDULED TO HAVE A HARDWARE REMOVAL DUE TO INFECTION. PREVIOUS CONSTRUCT WAS T3-L3, DEPUY SYNTHES SPINE VERSE PRODUCT WAS USED. L3 LEVEL OF THE CONSTRUCT, SHAFT OF THE SCREW WAS BROKE ON THE RIGHT SIDE, L3 LEFT PEDICLE SCREW, TULIP WAS COMPLETELY SEPARATED FROM THE SHAFT OF THE SCREW. ALL OF THE UNITIZED SET SCREWS PRODUCT CODE 199721001 WE LOOSE AND ALMOST DISENGAGING FROM THE TULIP. ALL OF THE UNITIZED SET SCREWS WERE VERY LOOSE. PATIENT CONSEQUENCE?: YES. PATIENT CONSEQUENCE DESCRIPTION:PATIENT HAD REVISION OF PREVIOUS SPINAL FUSION WHERE ALL OF THE HARDWARE WAS REMOVED. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES. SEE RELATED INCIDENT (B)(4) FOR REMAINING PRODUCTS.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7332011 ↗