EXPEDIUM VERSE 199721430Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034442648), received between Jun 20, 2019 and Jun 24, 2020 — classified as 5 injuries, 1 malfunction.

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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2020Adverse 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 ON AN UNKNOWN DATE THAT DURING A REMOVAL SURGERY OF A SPINE CONSTRUCT DUE TO INFECTION ON (B)(6) 2020, THE SURGEON WAS PLACED THE PATIENT IN A BRACE DUE TO POOR BONE QUALITY AND TERMINAL CANCER. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020. IT WAS UNKNOWN IF THE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) 5.5 EXP VERSE SCREW 4.35 X 30. THIS IS REPORT 3 OF 5 FOR (B)(4). RELATED PRODUCT COMPLAINTS: (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10192194 ↗
• InjuryJun 24, 2020Adverse 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 ON AN UNKNOWN DATE THAT DURING A REMOVAL SURGERY OF A SPINE CONSTRUCT DUE TO INFECTION ON (B)(6) 2020, THE SURGEON WAS PLACED THE PATIENT IN A BRACE DUE TO POOR BONE QUALITY AND TERMINAL CANCER. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020. IT WAS UNKNOWN IF THE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) 5.5 EXP VERSE SCREW 4.35 X 30. THIS IS REPORT 2 OF 5 FOR (B)(4). RELATED PRODUCT COMPLAINTS: (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10192191 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10192187 ↗
• InjuryJun 24, 2020Adverse 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 ON AN UNKNOWN DATE THAT DURING A REMOVAL SURGERY OF A SPINE CONSTRUCT DUE TO INFECTION ON (B)(6) 2020, THE SURGEON WAS PLACED THE PATIENT IN A BRACE DUE TO POOR BONE QUALITY AND TERMINAL CANCER. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020. IT WAS UNKNOWN IF THE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 5.5 EXP VERSE UNITIZED SET SCR. THIS IS REPORT 5 OF 10 FOR (B)(4). RELATED PRODUCT COMPLAINTS: (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10190848 ↗
• InjuryJun 24, 2020Adverse 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 ON AN UNKNOWN DATE THAT DURING A REMOVAL SURGERY OF A SPINE CONSTRUCT DUE TO INFECTION ON (B)(6) 2020, THE SURGEON WAS PLACED THE PATIENT IN A BRACE DUE TO POOR BONE QUALITY AND TERMINAL CANCER. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020. IT WAS UNKNOWN IF THE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 5.5 EXP VERSE SCREW 4.35 X 30. THIS IS REPORT 4 OF 10 FOR (B)(4). RELATED PRODUCT COMPLAINTS: (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10190807 ↗
• MalfunctionJun 20, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING SCOLIOSIS SURGERY A SCREW WAS BROKEN ON A T10-L2 COBALT COM ROD. SCREW WAS REMOVED AND WAS REPLACED, PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8718341 ↗