EXPEDIUM VERSE 199721635Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705034442297), received between May 11, 2020 and Aug 22, 2024 — classified as 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A RESTOCK ORDER WAS PLACED FOR EXPEDIUM VERSE, AND THE TABS WERE BROKEN OFF OF TWO OF THE SCREWS AND REPACKAGED. THERE WAS NO PATIENT INVOLVEMENT. SALES REP ALSO SENT A 4 LEVEL VECTRA PLATE IN THE SAME BOX. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 6.0 X 35MM THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031394 ↗
• MalfunctionJul 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, THERE WAS A POSSIBLE VERSE SCREW AND/OR CORRECTION KEY FAILURE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 6.0 X 35MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15074588 ↗
• MalfunctionApr 23, 2021Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED BY APPLYING A 5.0X35 SCREW. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF TWENTY (20) MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11712634 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONALLY IT WAS REPORTED THAT ON (B)(6) 2018 PATIENT A SUBSEQUENT REMOVAL OF SPINAL HARDWARE INCLUDING BILATERAL RODS, T2 HOOKS BILATERALLY, RIGHT T5 SCREW AND LEFT T9 AND T10. THIS INTERVENTION WAS NOTED FOR PARTIAL CORRECTION OF PATIENT'S DEFORMITY.

  Patient problems: Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10043704 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONALLY IT WAS REPORTED THAT ON (B)(6) 2018 PATIENT A SUBSEQUENT REMOVAL OF SPINAL HARDWARE INCLUDING BILATERAL RODS, T2 HOOKS BILATERALLY, RIGHT T5 SCREW AND LEFT T9 AND T10. THIS INTERVENTION WAS NOTED FOR PARTIAL CORRECTION OF PATIENT'S DEFORMITY.

  Patient problems: Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10043677 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONALLY IT WAS REPORTED THAT ON (B)(6) 2018 PATIENT A SUBSEQUENT REMOVAL OF SPINAL HARDWARE INCLUDING BILATERAL RODS, T2 HOOKS BILATERALLY, RIGHT T5 SCREW AND LEFT T9 AND T10. THIS INTERVENTION WAS NOTED FOR PARTIAL CORRECTION OF PATIENT'S DEFORMITY.

  Patient problems: Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10043668 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, ON (B)(6) 2015, THE PATIENT PRESENTED WITH THE COMPLAINTS OF SHOULDER PAIN WHICH REVEALED SCOLIOSIS OBTAINED ON RADIOLOGICAL STUDIES. HOWEVER, THEY FAILED TO DIAGNOSE SCOLIOSIS OR HAVE THE PATIENT SCOLIOSIS EVALUATION. ON (B)(6) 2018, THE PATIENT CAME WITH THE COMPLAINTS OF UPPER BACK PAIN PRIMARILY IN THE LEFT-MID-THORACIC SPINE RADIATING TO THE LEFT AND RIGHT BUTTOCKS. THE PAIN WAS INTERMITTENT, MODERATE ACHE WITH NO HISTORY OF BACK PAIN BEFORE. ON (B)(6) 2018, THE PATIENT EXPLAINED THAT HE HAD LOW BACK PAIN AND OCCASIONAL THIGH PAIN. THE PATIENT DENIED OF RADIATING PAIN, NUMBNESS OR TINGLING IN HER EXTREMITIES. THE PATIENT WAS SCHEDULED THEN WITH POSTERIOR INSTRUMENTED FUSION T2 TO L4 VERTEBRAL BODIES. THE NEED FOR THE SURGERY WAS URGENT BECAUSE IT WAS NOT DETECTED EARLIER. ON (B)(6) 2018, THE SURGEON RECOMMENDED AND AGREED TO HAVE URGENT SURGERY TO THE PATIENT WITH MORE CONSERVATIVE TREATMENT. ON (B)(6) 2018, THEY BEGAN THE SURGERY (POSTERIOR INSTRUMENTED FUSION T2 TO L4. BUT WHEN THE PATIENT AWOKE FROM THE SURGERY, THE PATIENT WAS COMPLETELY PARALYZED FROM HER CHEST DOWN WITH THE MOTOR-SENSORY LOSS FROM T4 TO HER TOES. AND NOW SUFFERS FROM D

  Patient problems: Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10043667 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONALLY IT WAS REPORTED THAT ON JUNE 26, 2018 PATIENT A SUBSEQUENT REMOVAL OF SPINAL HARDWARE INCLUDING BILATERAL RODS, T2 HOOKS BILATERALLY, RIGHT T5 SCREW AND LEFT T9 AND T10. THIS INTERVENTION WAS NOTED FOR PARTIAL CORRECTION OF PATIENT'S DEFORMITY.

  Patient problems: Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10043662 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONALLY IT WAS REPORTED THAT ON (B)(6) 2018 PATIENT A SUBSEQUENT REMOVAL OF SPINAL HARDWARE INCLUDING BILATERAL RODS, T2 HOOKS BILATERALLY, RIGHT T5 SCREW AND LEFT T9 AND T10. THIS INTERVENTION WAS NOTED FOR PARTIAL CORRECTION OF PATIENT'S DEFORMITY.

  Patient problems: Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10043661 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, ON (B)(6) 2015, THE PATIENT PRESENTED WITH THE COMPLAINTS OF SHOULDER PAIN WHICH REVEALED SCOLIOSIS OBTAINED ON RADIOLOGICAL STUDIES. HOWEVER, THEY FAILED TO DIAGNOSE SCOLIOSIS OR HAVE THE PATIENT SCOLIOSIS EVALUATION. ON (B)(6) 2018, THE PATIENT CAME WITH THE COMPLAINTS OF UPPER BACK PAIN PRIMARILY IN THE LEFT-MID-THORACIC SPINE RADIATING TO THE LEFT AND RIGHT BUTTOCKS. THE PAIN WAS INTERMITTENT, MODERATE ACHE WITH NO HISTORY OF BACK PAIN BEFORE. ON (B)(6) 2018, THE PATIENT EXPLAINED THAT HE HAD LOW BACK PAIN AND OCCASIONAL THIGH PAIN. THE PATIENT DENIED OF RADIATING PAIN, NUMBNESS OR TINGLING IN HER EXTREMITIES. THE PATIENT WAS SCHEDULED THEN WITH POSTERIOR INSTRUMENTED FUSION T2 TO L4 VERTEBRAL BODIES. THE NEED FOR THE SURGERY WAS URGENT BECAUSE IT WAS NOT DETECTED EARLIER. ON (B)(6) 2018, THE SURGEON RECOMMENDED AND AGREED TO HAVE URGENT SURGERY TO THE PATIENT WITH MORE CONSERVATIVE TREATMENT. ON (B)(6) 2018, THEY BEGAN THE SURGERY (POSTERIOR INSTRUMENTED FUSION T2 TO L4. BUT WHEN THE PATIENT AWOKE FROM THE SURGERY, THE PATIENT WAS COMPLETELY PARALYZED FROM HER CHEST DOWN WITH THE MOTOR-SENSORY LOSS FROM T4 TO HER TOES. AND NOW SUFFERS FROM D

  Patient problems: Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10043658 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, ON (B)(6) 2015, THE PATIENT PRESENTED WITH THE COMPLAINTS OF SHOULDER PAIN WHICH REVEALED SCOLIOSIS OBTAINED ON RADIOLOGICAL STUDIES. HOWEVER, THEY FAILED TO DIAGNOSE SCOLIOSIS OR HAVE THE PATIENT SCOLIOSIS EVALUATION. ON (B)(6) 2018, THE PATIENT CAME WITH THE COMPLAINTS OF UPPER BACK PAIN PRIMARILY IN THE LEFT-MID-THORACIC SPINE RADIATING TO THE LEFT AND RIGHT BUTTOCKS. THE PAIN WAS INTERMITTENT, MODERATE ACHE WITH NO HISTORY OF BACK PAIN BEFORE. ON (B)(6) 2018, THE PATIENT EXPLAINED THAT HE HAD LOW BACK PAIN AND OCCASIONAL THIGH PAIN. THE PATIENT DENIED OF RADIATING PAIN, NUMBNESS OR TINGLING IN HER EXTREMITIES. THE PATIENT WAS SCHEDULED THEN WITH POSTERIOR INSTRUMENTED FUSION T2 TO L4 VERTEBRAL BODIES. THE NEED FOR THE SURGERY WAS URGENT BECAUSE IT WAS NOT DETECTED EARLIER. ON (B)(6) 2018, THE SURGEON RECOMMENDED AND AGREED TO HAVE URGENT SURGERY TO THE PATIENT WITH MORE CONSERVATIVE TREATMENT. ON (B)(6) 2018, THEY BEGAN THE SURGERY (POSTERIOR INSTRUMENTED FUSION T2 TO L4. BUT WHEN THE PATIENT AWOKE FROM THE SURGERY, THE PATIENT WAS COMPLETELY PARALYZED FROM HER CHEST DOWN WITH THE MOTOR-SENSORY LOSS FROM T4 TO HER TOES. AND NOW SUFFERS FROM D

  Patient problems: Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10043655 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONALLY IT WAS REPORTED THAT ON (B)(6), 2018 PATIENT A SUBSEQUENT REMOVAL OF SPINAL HARDWARE INCLUDING BILATERAL RODS, T2 HOOKS BILATERALLY, RIGHT T5 SCREW AND LEFT T9 AND T10. THIS INTERVENTION WAS NOTED FOR PARTIAL CORRECTION OF PATIENT'S DEFORMITY.

  Patient problems: Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10043653 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, ON (B)(6) 2015, THE PATIENT PRESENTED WITH THE COMPLAINTS OF SHOULDER PAIN WHICH REVEALED SCOLIOSIS OBTAINED ON RADIOLOGICAL STUDIES. HOWEVER, THEY FAILED TO DIAGNOSE SCOLIOSIS OR HAVE THE PATIENT SCOLIOSIS EVALUATION. ON (B)(6) 2018, THE PATIENT CAME WITH THE COMPLAINTS OF UPPER BACK PAIN PRIMARILY IN THE LEFT-MID-THORACIC SPINE RADIATING TO THE LEFT AND RIGHT BUTTOCKS. THE PAIN WAS INTERMITTENT, MODERATE ACHE WITH NO HISTORY OF BACK PAIN BEFORE. ON (B)(6) 2018, THE PATIENT EXPLAINED THAT HE HAD LOW BACK PAIN AND OCCASIONAL THIGH PAIN. THE PATIENT DENIED OF RADIATING PAIN, NUMBNESS OR TINGLING IN HER EXTREMITIES. THE PATIENT WAS SCHEDULED THEN WITH POSTERIOR INSTRUMENTED FUSION T2 TO L4 VERTEBRAL BODIES. THE NEED FOR THE SURGERY WAS URGENT BECAUSE IT WAS NOT DETECTED EARLIER. ON (B)(6) 2018, THE SURGEON RECOMMENDED AND AGREED TO HAVE URGENT SURGERY TO THE PATIENT WITH MORE CONSERVATIVE TREATMENT. ON (B)(6) 2018, THEY BEGAN THE SURGERY (POSTERIOR INSTRUMENTED FUSION T2 TO L4. BUT WHEN THE PATIENT AWOKE FROM THE SURGERY, THE PATIENT WAS COMPLETELY PARALYZED FROM HER CHEST DOWN WITH THE MOTOR-SENSORY LOSS FROM T4 TO HER TOES. AND NOW SUFFERS FROM D

  Patient problems: Neurological Deficit/Dysfunction; Paralysis; Unspecified Nervous System Problem

  MAUDE report 10043650 ↗