EXPEDIUM VERSE 199721530Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10705034442471), received between Jul 14, 2022 and Aug 3, 2022 — classified as 29 injuries.

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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 A PATIENT HAS BEEN SUBJECTED TO A FIRST INTERVENTION FOR WASHING THE WOUND AT THE IMPLANT SITE DUE TO METAL INTOLERANCE. SUBSEQUENTLY THE PATIENT HAS BEEN REVISED ON AN UNKNOWN DATE FOR REMOVAL OF MEDIA SYNTHESIS. A SECOND SURGERY IS NEEDED TO REMOVE THE BROKEN SCREWS. PATIENT OUTCOME IS REPORTED AS OKAY, NO COMPLICATIONS. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE SCREW 5.0 X 30 THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15160987 ↗
• InjuryJul 18, 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 10 OF 12 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15046214 ↗
• InjuryJul 18, 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 12 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15046170 ↗
• InjuryJul 18, 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 12 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15045953 ↗
• InjuryJul 18, 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 9 OF 12 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15045865 ↗
• InjuryJul 18, 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 7 OF 12 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15045852 ↗
• InjuryJul 18, 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 20 OF 20 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15043675 ↗
• InjuryJul 18, 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 12 OF 12 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15040941 ↗
• InjuryJul 15, 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 12 OF 12 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15031915 ↗
• InjuryJul 15, 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 12 OF 12 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15029055 ↗
• InjuryJul 15, 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 12 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15029036 ↗
• InjuryJul 15, 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 10 OF 12 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15029011 ↗
• InjuryJul 15, 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 9 OF 12 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15028992 ↗
• InjuryJul 15, 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 12 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15028957 ↗
• InjuryJul 15, 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 20 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15027712 ↗
• InjuryJul 15, 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 10 OF 20 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15027677 ↗
• InjuryJul 15, 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 9 OF 20 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15027659 ↗
• InjuryJul 15, 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 20 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15027641 ↗
• InjuryJul 15, 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 20 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15027576 ↗
• InjuryJul 14, 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 SURGICAL INFECTION. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE PATIENT EXPERIENCED ADDITIONAL HOSPITALIZATION AND SURGICAL CLEANING. THIS REPORT IS FOR AN EXPEDIUM SCREW. THIS IS REPORT 13 OF 20 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15017631 ↗
• InjuryJul 14, 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 SURGICAL INFECTION. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE PATIENT EXPERIENCED ADDITIONAL HOSPITALIZATION AND SURGICAL CLEANING. THIS REPORT IS FOR AN EXPEDIUM SCREW. THIS IS REPORT 11 OF 20 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15017545 ↗
• InjuryJul 14, 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 SURGICAL INFECTION. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE PATIENT EXPERIENCED ADDITIONAL HOSPITALIZATION AND SURGICAL CLEANING. THIS REPORT IS FOR AN EXPEDIUM SCREW. THIS IS REPORT 12 OF 20 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15017505 ↗
• InjuryJul 14, 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 SURGICAL INFECTION. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE PATIENT EXPERIENCED ADDITIONAL HOSPITALIZATION AND SURGICAL CLEANING. THIS REPORT IS FOR AN EXPEDIUM SCREW. THIS IS REPORT 9 OF 20 FOR (B)(4)..

  Patient problems: Unspecified Infection

  MAUDE report 15017427 ↗
• InjuryJul 14, 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 SURGICAL INFECTION. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE PATIENT EXPERIENCED ADDITIONAL HOSPITALIZATION AND SURGICAL CLEANING. THIS REPORT IS FOR AN EXPEDIUM SCREW. THIS IS REPORT 10 OF 20 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15017395 ↗
• InjuryJul 14, 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 SURGICAL INFECTION. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE PATIENT EXPERIENCED ADDITIONAL HOSPITALIZATION AND SURGICAL CLEANING. THIS REPORT IS FOR AN EXPEDIUM SCREW. THIS IS REPORT 8 OF 20 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15017323 ↗