EXPEDIUM VERSE 199721535Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10705034442464), received between Nov 12, 2019 and Oct 1, 2025 — classified as 46 injuries.

The most frequently reported specific device problem is “Break” (2 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 46 reports, in the reporter's own words as published by the FDA.

• InjuryOct 1, 2025Break; Entrapment of Device; Break; Entrapment of Device

  ADDITIONAL INFORMATION RECEIVED STATES THAT DURING THE PROCEDURE OF REINTERVENTION TO REMOVE THE SCREWS THAT STARTED FROM A PATIENT OPERATED ONE YEAR AGO; ONCE THE SURGICAL APPROACH WAS PERFORMED, TWO HEADS OF LOOSE SCREWS (BROKEN) REF (B)(4) LOT 370687 WERE EVIDENCED IN THE PATIENT WHICH WERE FIXED IN S1, WE PROCEED TO RELEASE THE CLOSING SCREWS, THE BARS, THE SCREWS AND THE HEADS OF THE TWO BROKEN SCREWS, BUT WHEN WE WANT TO REMOVE THEM THEY ARE NOT COMPLETE BECAUSE THE STEM OF EACH BROKEN SCREW IS INSIDE THE BODY OF THE VERTEBRA SINCE THESE RODS WERE NOT POSSIBLE TO REMOVE THEM. THE SPECIALIST REQUESTS THAT THESE HEADS OF THE BROKEN SCREWS BE SENT TO THE MANUFACTURER FOR QUALITY STUDY AND RESEARCH; COMPLYING WITH THE REQUEST OF THE SPECIALIST THESE ARE SENT MARKED WITH RED TAPE ALONG WITH THE REST OF THE DEVICES INSIDE THE EQUIPMENT # (B)(4) PACKED IN SURGICAL PAPER PACKAGING, MARKED WITH THE PATIENT DATA, SO THAT WHEN THEY ARRIVE AT J&J FACILITIES THEY ARE DELIVERED TO THE QUALITY AREA. THIS SURGERY PERFORMED WITHOUT CONSUMPTION BECAUSE IT IS A REMOVAL OF MATERIAL WAS FINISHED, WITHOUT ALTERATIONS IN THE SURGICAL TIMES, BUT IF WITH SOME DISCOMFORT ON THE PART OF THE SPECIALIST

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 23191126 ↗
• InjuryOct 1, 2025Break; Entrapment of Device; Break; Entrapment of Device

  ADDITIONAL INFORMATION RECEIVED STATES THAT DURING THE PROCEDURE OF REINTERVENTION TO REMOVE THE SCREWS THAT STARTED FROM A PATIENT OPERATED ONE YEAR AGO; ONCE THE SURGICAL APPROACH WAS PERFORMED, TWO HEADS OF LOOSE SCREWS (BROKEN) REF (B)(4) LOT 370687 WERE EVIDENCED IN THE PATIENT WHICH WERE FIXED IN S1, WE PROCEED TO RELEASE THE CLOSING SCREWS, THE BARS, THE SCREWS AND THE HEADS OF THE TWO BROKEN SCREWS, BUT WHEN WE WANT TO REMOVE THEM THEY ARE NOT COMPLETE BECAUSE THE STEM OF EACH BROKEN SCREW IS INSIDE THE BODY OF THE VERTEBRA SINCE THESE RODS WERE NOT POSSIBLE TO REMOVE THEM. THE SPECIALIST REQUESTS THAT THESE HEADS OF THE BROKEN SCREWS BE SENT TO THE MANUFACTURER FOR QUALITY STUDY AND RESEARCH; COMPLYING WITH THE REQUEST OF THE SPECIALIST THESE ARE SENT MARKED WITH RED TAPE ALONG WITH THE REST OF THE DEVICES INSIDE THE EQUIPMENT # (B)(4) PACKED IN SURGICAL PAPER PACKAGING, MARKED WITH THE PATIENT DATA, SO THAT WHEN THEY ARRIVE AT J&J FACILITIES THEY ARE DELIVERED TO THE QUALITY AREA. THIS SURGERY PERFORMED WITHOUT CONSUMPTION BECAUSE IT IS A REMOVAL OF MATERIAL WAS FINISHED, WITHOUT ALTERATIONS IN THE SURGICAL TIMES, BUT IF WITH SOME DISCOMFORT ON THE PART OF THE SPECIALIST

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 23190917 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 35. THIS IS REPORT 9 OF 18 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4)

  Patient problems: Unspecified Infection

  MAUDE report 15502653 ↗
• InjurySep 29, 2022Adverse 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 PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 35. THIS IS REPORT 7 OF 18 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15502651 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 35. THIS IS REPORT 14 OF 18 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15502512 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 35. THIS IS REPORT 17 OF 18 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15502507 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 35. THIS IS REPORT 11 OF 18 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15502492 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 35. THIS IS REPORT 5 OF 18 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15502488 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 35. THIS IS REPORT 12 OF 18 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15502456 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 35. THIS IS REPORT 8 OF 18 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15502439 ↗
• InjurySep 29, 2022Adverse 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 PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 35. THIS IS REPORT 4 OF 18 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15502432 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 35. THIS IS REPORT 2 OF 18 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15502347 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 35. THIS IS REPORT 1 OF 18 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15502343 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 35. THIS IS REPORT 18 OF 18 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15502300 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 35. THIS IS REPORT 16 OF 18 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15502296 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 35. THIS IS REPORT 10 OF 18 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15502293 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 35. THIS IS REPORT 15 OF 18 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER(B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15502290 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 35. THIS IS REPORT 13 OF 18 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15502276 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 35. THIS IS REPORT 6 OF 18 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15502275 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 35. THIS IS REPORT 3 OF 18 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15502265 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THE PATIENT EXPERIENCED A POST-OPERATIVE INFECTION. THIS IS REPORT 11 OF 13 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15501546 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THE PATIENT EXPERIENCED A POST-OPERATIVE INFECTION. THIS IS REPORT 8 OF 13 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15501542 ↗
• InjurySep 29, 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 THE PATIENT EXPERIENCED A POST-OPERATIVE INFECTION. THIS IS REPORT 12 OF 13 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15501435 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THE PATIENT EXPERIENCED A POST-OPERATIVE INFECTION. THIS IS REPORT 6 OF 13 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15501391 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THE PATIENT EXPERIENCED A POST-OPERATIVE INFECTION. THIS IS REPORT 13 OF 13 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15501380 ↗