EXPEDIUM VERSE 199721000SRecalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 10705034466125), received between Aug 30, 2017 and May 4, 2026 — classified as 21 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Break” (36 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 25 most recent of 97 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Difficult to Advance

  EXP VERSE CORRECTION KEY COULD NOT BE INSERTED CORRECTLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068329 ↗
• MalfunctionMay 4, 2026Difficult to Advance

  EXP VERSE CORRECTION KEY COULD NOT BE INSERTED CORRECTLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068328 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORT THAT THERE WAS SHEARING OFF OF METAL SHAVINGS WHEN THE CORRECTION KEY WAS INSERTED. A NEW CORRECTION KEY WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729232 ↗
• MalfunctionFeb 19, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED DURING A SCOLIOSE SURGERY TH3-L2, SPINE PROCEDURE, THE DEVICE COULD NOT BE INSERTED CORRECTLY INTRAOPERATIVELY, NECESSITATING THE EXCHANGE OF THE SET-SCREW. THE EVENT INVOLVED THE DEVICE BREAKING INTO TWO OR MORE PIECES, WITH FRAGMENTS GENERATED. FRAGMENTS WERE REMOVED. THERE WAS NO DELAY IN SURGERY, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING NEW SET SCREWS. NO PATIENT CONSEQUENCES OR IMPACT WERE REPORTED, AND NO ADDITIONAL MEDICAL INTERVENTION WAS INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24391809 ↗
• MalfunctionFeb 19, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED DURING A SCOLIOSE SURGERY TH3-L2, SPINE PROCEDURE, THE DEVICE COULD NOT BE INSERTED CORRECTLY INTRAOPERATIVELY, NECESSITATING THE EXCHANGE OF THE SET-SCREW. THE EVENT INVOLVED THE DEVICE BREAKING INTO TWO OR MORE PIECES, WITH FRAGMENTS GENERATED. FRAGMENTS WERE REMOVED. THERE WAS NO DELAY IN SURGERY, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING NEW SET SCREWS. NO PATIENT CONSEQUENCES OR IMPACT WERE REPORTED, AND NO ADDITIONAL MEDICAL INTERVENTION WAS INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24391676 ↗
• MalfunctionJan 13, 2026Break; Mechanical Jam

  WHEN APPLYING THE CORRECTION TIGHTENING NUT, IT WOULD LOCK WHEN THE OUTER (BLUE) PORTION IS CLOSED DYNAMICALLY; THE NUT WAS REMOVED. IT WAS PRESENTED WITH THE THREAD PORTION COMPLETELY BROKEN. SEVERAL METAL FRAGMENTS OF BROKEN NUT THREAD WERE FOUND IN THE WORKING CANAL OF THE SCREW AND IN THE SURGICAL AREA, SOME OF THEM STUCK IN THE TULIP OF THE SCREW OR IN ITS EXTENSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053486 ↗
• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED DURING A DORSALE KORREKTURSPONDYLODESE TH12-ILEUM PROCEDURE, THERE WAS DETACHMENT OF METAL CHIPS WHEN THE SET SCREW OF THE CORRECTION KEY ARE INSERTED. SURGERY WAS DELAYED 30 MINUTES. REPLACEMENT OF SCREW AND INNIES WAS NEEDED. PROCEDURE WAS SUCCESSFULLY COMPLETED. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876520 ↗
• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED DURING A DORSALE KORREKTURSPONDYLODESE TH12-ILEUM PROCEDURE, THERE WAS DETACHMENT OF METAL CHIPS WHEN THE SET SCREW OF THE CORRECTION KEY ARE INSERTED. SURGERY WAS DELAYED 30 MINUTES. REPLACEMENT OF SCREW AND INNIES WAS NEEDED. PROCEDURE WAS SUCCESSFULLY COMPLETED. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876512 ↗
• MalfunctionDec 23, 2025Break; Device Slipped; Break; Device Slipped

  IT WAS REPORTED DURING TH3-L1/2 PROCEDURE WHILE TIGHTENING THE SET SCREWS, METAL FRAGMENTS ARE COMING LOOSE. SURGERY WAS DELAYED 30 MINUTES. FRAGMENTS WERE REMOVED FROM PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876202 ↗
• MalfunctionDec 23, 2025Break; Device Slipped; Break; Device Slipped

  IT WAS REPORTED DURING TH3-L1/2 PROCEDURE WHILE TIGHTENING THE SET SCREWS, METAL FRAGMENTS ARE COMING LOOSE. SURGERY WAS DELAYED 30 MINUTES. FRAGMENTS WERE REMOVED FROM PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876196 ↗
• MalfunctionDec 23, 2025Break; Device Slipped; Break; Device Slipped

  IT WAS REPORTED DURING TH3-L1/2 PROCEDURE WHILE TIGHTENING THE SET SCREWS, METAL FRAGMENTS ARE COMING LOOSE. SURGERY WAS DELAYED 30 MINUTES. FRAGMENTS WERE REMOVED FROM PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876184 ↗
• MalfunctionDec 2, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED A DURING A SCOLIOSIS TH2-L1 PROCEDURE THE DEVICES BROKE. AFTER THE INSERTION OF THE RODS AND CORRECTION CAP SCREWS AND THE FINAL UNSCREWING OF THE POLYAXIAL LOCK, THREADS FROM THE EXP VERSE SCREW HEAD ARE BROKE IN THE ROD LOCKING IN L2. NO CORRECTION IS POSSIBLE. ALL THE CORRECTION SCREWS THAT HAD BEEN INSERTED HAD TO BE LOOSENED AND DISCARDED SINCE THEY HAD ALREADY BEEN TURNED OFF. THE EXP VERSE SCREW HAD TO BE REMOVED AND REPLACED. NO ALLEGATION AGAINST THE ROD. SURGERY WAS DELAYED 30 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES. DURING DEVICE RETURN IT WAS DETERMINED DURING VISUAL EXAMINATION THAT ADDITIONAL SCREWS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691537 ↗
• MalfunctionDec 2, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED A DURING A SCOLIOSIS TH2-L1 PROCEDURE THE DEVICES BROKE. AFTER THE INSERTION OF THE RODS AND CORRECTION CAP SCREWS AND THE FINAL UNSCREWING OF THE POLYAXIAL LOCK, THREADS FROM THE EXP VERSE SCREW HEAD ARE BROKE IN THE ROD LOCKING IN L2. NO CORRECTION IS POSSIBLE. ALL THE CORRECTION SCREWS THAT HAD BEEN INSERTED HAD TO BE LOOSENED AND DISCARDED SINCE THEY HAD ALREADY BEEN TURNED OFF. THE EXP VERSE SCREW HAD TO BE REMOVED AND REPLACED. NO ALLEGATION AGAINST THE ROD. SURGERY WAS DELAYED 30 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES. DURING DEVICE RETURN IT WAS DETERMINED DURING VISUAL EXAMINATION THAT ADDITIONAL SCREWS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691531 ↗
• MalfunctionDec 2, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED A DURING A SCOLIOSIS TH2-L1 PROCEDURE THE DEVICES BROKE. AFTER THE INSERTION OF THE RODS AND CORRECTION CAP SCREWS AND THE FINAL UNSCREWING OF THE POLYAXIAL LOCK, THREADS FROM THE EXP VERSE SCREW HEAD ARE BROKE IN THE ROD LOCKING IN L2. NO CORRECTION IS POSSIBLE. ALL THE CORRECTION SCREWS THAT HAD BEEN INSERTED HAD TO BE LOOSENED AND DISCARDED SINCE THEY HAD ALREADY BEEN TURNED OFF. THE EXP VERSE SCREW HAD TO BE REMOVED AND REPLACED. NO ALLEGATION AGAINST THE ROD. SURGERY WAS DELAYED 30 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES. DURING DEVICE RETURN IT WAS DETERMINED DURING VISUAL EXAMINATION THAT ADDITIONAL SCREWS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691526 ↗
• MalfunctionDec 2, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED A DURING A SCOLIOSIS TH2-L1 PROCEDURE THE DEVICES BROKE. AFTER THE INSERTION OF THE RODS AND CORRECTION CAP SCREWS AND THE FINAL UNSCREWING OF THE POLYAXIAL LOCK, THREADS FROM THE EXP VERSE SCREW HEAD ARE BROKE IN THE ROD LOCKING IN L2. NO CORRECTION IS POSSIBLE. ALL THE CORRECTION SCREWS THAT HAD BEEN INSERTED HAD TO BE LOOSENED AND DISCARDED SINCE THEY HAD ALREADY BEEN TURNED OFF. THE EXP VERSE SCREW HAD TO BE REMOVED AND REPLACED. NO ALLEGATION AGAINST THE ROD. SURGERY WAS DELAYED 30 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES. DURING DEVICE RETURN IT WAS DETERMINED DURING VISUAL EXAMINATION THAT ADDITIONAL SCREWS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691523 ↗
• MalfunctionDec 2, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED A DURING A SCOLIOSIS TH2-L1 PROCEDURE THE DEVICES BROKE. AFTER THE INSERTION OF THE RODS AND CORRECTION CAP SCREWS AND THE FINAL UNSCREWING OF THE POLYAXIAL LOCK, THREADS FROM THE EXP VERSE SCREW HEAD ARE BROKE IN THE ROD LOCKING IN L2. NO CORRECTION IS POSSIBLE. ALL THE CORRECTION SCREWS THAT HAD BEEN INSERTED HAD TO BE LOOSENED AND DISCARDED SINCE THEY HAD ALREADY BEEN TURNED OFF. THE EXP VERSE SCREW HAD TO BE REMOVED AND REPLACED. NO ALLEGATION AGAINST THE ROD. SURGERY WAS DELAYED 30 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES. DURING DEVICE RETURN IT WAS DETERMINED DURING VISUAL EXAMINATION THAT ADDITIONAL SCREWS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691517 ↗
• MalfunctionDec 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED A DURING A SCOLIOSIS TH2-L1 PROCEDURE THE DEVICES BROKE. AFTER THE INSERTION OF THE RODS AND CORRECTION CAP SCREWS AND THE FINAL UNSCREWING OF THE POLYAXIAL LOCK, THREADS FROM THE EXP VERSE SCREW HEAD ARE BROKE IN THE ROD LOCKING IN L2. NO CORRECTION IS POSSIBLE. ALL THE CORRECTION SCREWS THAT HAD BEEN INSERTED HAD TO BE LOOSENED AND DISCARDED SINCE THEY HAD ALREADY BEEN TURNED OFF. THE EXP VERSE SCREW HAD TO BE REMOVED AND REPLACED. NO ALLEGATION AGAINST THE ROD. SURGERY WAS DELAYED 30 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES. DURING DEVICE RETURN IT WAS DETERMINED DURING VISUAL EXAMINATION THAT ADDITIONAL SCREWS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691493 ↗
• MalfunctionDec 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED A DURING A SCOLIOSIS TH2-L1 PROCEDURE THE DEVICES BROKE. AFTER THE INSERTION OF THE RODS AND CORRECTION CAP SCREWS AND THE FINAL UNSCREWING OF THE POLYAXIAL LOCK, THREADS FROM THE EXP VERSE SCREW HEAD ARE BROKE IN THE ROD LOCKING IN L2. NO CORRECTION IS POSSIBLE. ALL THE CORRECTION SCREWS THAT HAD BEEN INSERTED HAD TO BE LOOSENED AND DISCARDED SINCE THEY HAD ALREADY BEEN TURNED OFF. THE EXP VERSE SCREW HAD TO BE REMOVED AND REPLACED. NO ALLEGATION AGAINST THE ROD. SURGERY WAS DELAYED 30 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES. DURING DEVICE RETURN IT WAS DETERMINED DURING VISUAL EXAMINATION THAT ADDITIONAL SCREWS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691483 ↗
• MalfunctionDec 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED A DURING A SCOLIOSIS TH2-L1 PROCEDURE THE DEVICES BROKE. AFTER THE INSERTION OF THE RODS AND CORRECTION CAP SCREWS AND THE FINAL UNSCREWING OF THE POLYAXIAL LOCK, THREADS FROM THE EXP VERSE SCREW HEAD ARE BROKE IN THE ROD LOCKING IN L2. NO CORRECTION IS POSSIBLE. ALL THE CORRECTION SCREWS THAT HAD BEEN INSERTED HAD TO BE LOOSENED AND DISCARDED SINCE THEY HAD ALREADY BEEN TURNED OFF. THE EXP VERSE SCREW HAD TO BE REMOVED AND REPLACED. NO ALLEGATION AGAINST THE ROD. SURGERY WAS DELAYED 30 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES. DURING DEVICE RETURN IT WAS DETERMINED DURING VISUAL EXAMINATION THAT ADDITIONAL SCREWS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691479 ↗
• MalfunctionDec 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED A DURING A SCOLIOSIS TH2-L1 PROCEDURE THE DEVICES BROKE. AFTER THE INSERTION OF THE RODS AND CORRECTION CAP SCREWS AND THE FINAL UNSCREWING OF THE POLYAXIAL LOCK, THREADS FROM THE EXP VERSE SCREW HEAD ARE BROKE IN THE ROD LOCKING IN L2. NO CORRECTION IS POSSIBLE. ALL THE CORRECTION SCREWS THAT HAD BEEN INSERTED HAD TO BE LOOSENED AND DISCARDED SINCE THEY HAD ALREADY BEEN TURNED OFF. THE EXP VERSE SCREW HAD TO BE REMOVED AND REPLACED. NO ALLEGATION AGAINST THE ROD. SURGERY WAS DELAYED 30 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES. DURING DEVICE RETURN IT WAS DETERMINED DURING VISUAL EXAMINATION THAT ADDITIONAL SCREWS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691466 ↗
• MalfunctionSep 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE PRODUCT WAS WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075449 ↗
• MalfunctionJun 25, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE EXPEDIUM VERSE SYSTEM WAS USED AND DURING INSERTION, A SCREW 7MM L50 COULD NOT BE INSERTED, AS THIS LOOSENED WHEN THE SET SCREW WAS SCREWED IN. IN ADDITION, A TOTAL OF FIVE SET SCREWS COULD NOT BE SCREWED IN, AS THEY WERE PARTIALLY BROKEN DURING THE SCREW-IN TEST. THERE WAS A FIFTEEN (15) MINUTE SURGICAL DELAY. THERE WERE NO FRAGMENTS GENERATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328293 ↗
• MalfunctionApr 23, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THE EXPEDIUM VERSE SYSTEM WAS USED DURING A PROCEDURE AND DURING INSERTION, A SCREW 7MM L50 COULD NOT BE INSERTED. THE SCREW LOOSENED WHEN THE SET SCREW WAS SCREWED IN. IN ADDITION, A TOTAL OF FIVE SET SCREWS COULD NOT BE SCREWED IN, AS THEY WERE PARTIALLY BROKEN DURING THE SCREW-IN TEST. NO BROKEN FRAGMENTS WERE RETAINED IN THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 15 MINUTE SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21891348 ↗
• MalfunctionApr 23, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THE EXPEDIUM VERSE SYSTEM WAS USED DURING A PROCEDURE AND DURING INSERTION, A SCREW 7MM L50 COULD NOT BE INSERTED. THE SCREW LOOSENED WHEN THE SET SCREW WAS SCREWED IN. IN ADDITION, A TOTAL OF FIVE SET SCREWS COULD NOT BE SCREWED IN, AS THEY WERE PARTIALLY BROKEN DURING THE SCREW-IN TEST. NO BROKEN FRAGMENTS WERE RETAINED IN THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 15 MINUTE SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21890982 ↗
• MalfunctionApr 23, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THE EXPEDIUM VERSE SYSTEM WAS USED DURING A PROCEDURE AND DURING INSERTION, A SCREW 7MM L50 COULD NOT BE INSERTED. THE SCREW LOOSENED WHEN THE SET SCREW WAS SCREWED IN. IN ADDITION, A TOTAL OF FIVE SET SCREWS COULD NOT BE SCREWED IN, AS THEY WERE PARTIALLY BROKEN DURING THE SCREW-IN TEST. NO BROKEN FRAGMENTS WERE RETAINED IN THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 15 MINUTE SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21890829 ↗