EXPEDIUM VERSE 199723655SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034443546), received between Jul 22, 2022 and Jan 8, 2024 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: IMPLANT FAILURE, COMPLICATION TIME/INTERVENTION, REPEAT SURGERY. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 6.0 X 55MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18466234 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SALES REP WAS CONTACTED BY SURGEON¿S OFFICE STAFF ON 9/27/2023 REQUESTING THE METAL COMPOSITION FOR IMPLANTS USED ON A PATIENT . HE EMAILED SURGEON AND HIS STAFF DIRECTLY AFTER BEING CONTACTED. HE PROVIDED THEM WITH THE REQUESTED INFORMATION FOR EXPEDIUM AND METAL COMPOSITION BREAKDOWNS. THEY SAID THE PATIENT WAS EXPERIENCING SWELLING, REDNESS AND IRRITATION IN HIS ABDOMEN. POTENTIALLY MAY BE HAVING A REACTION TO THE IMPLANTS. HE WAS CONTACTED AGAIN BY SURGEON¿S OFFICE THIS AFTERNOON. THE PATIENT WAS REFERRED TO A DERMATOLOGIST AND SURGEON¿S OFFICE ASKED IF WE COULD PROVIDE "PATCH TEST KIT¿. THIS REPORT IS FOR ONE (1)5.5 EXP VERSE FEN SCR 6.0X55. THIS IS REPORT 8 OF 10 FOR COMPLAINT: (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 17939994 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SALES REP WAS CONTACTED BY SURGEON¿S OFFICE STAFF ON 9/27/2023 REQUESTING THE METAL COMPOSITION FOR IMPLANTS USED ON A PATIENT . HE EMAILED SURGEON AND HIS STAFF DIRECTLY AFTER BEING CONTACTED. HE PROVIDED THEM WITH THE REQUESTED INFORMATION FOR EXPEDIUM AND METAL COMPOSITION BREAKDOWNS. THEY SAID THE PATIENT WAS EXPERIENCING SWELLING, REDNESS AND IRRITATION IN HIS ABDOMEN. POTENTIALLY MAY BE HAVING A REACTION TO THE IMPLANTS. HE WAS CONTACTED AGAIN BY SURGEON¿S OFFICE THIS AFTERNOON. THE PATIENT WAS REFERRED TO A DERMATOLOGIST AND SURGEON¿S OFFICE ASKED IF WE COULD PROVIDE "PATCH TEST KIT¿. THIS REPORT IS FOR ONE (1)5.5 EXP VERSE FEN SCR 6.0X55. THIS IS REPORT 7 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 17939983 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SALES REP WAS CONTACTED BY SURGEON¿S OFFICE STAFF ON 9/27/2023 REQUESTING THE METAL COMPOSITION FOR IMPLANTS USED ON A PATIENT . HE EMAILED SURGEON AND HIS STAFF DIRECTLY AFTER BEING CONTACTED. HE PROVIDED THEM WITH THE REQUESTED INFORMATION FOR EXPEDIUM AND METAL COMPOSITION BREAKDOWNS. THEY SAID THE PATIENT WAS EXPERIENCING SWELLING, REDNESS AND IRRITATION IN HIS ABDOMEN. POTENTIALLY MAY BE HAVING A REACTION TO THE IMPLANTS. HE WAS CONTACTED AGAIN BY SURGEON¿S OFFICE THIS AFTERNOON. THE PATIENT WAS REFERRED TO A DERMATOLOGIST AND SURGEON¿S OFFICE ASKED IF WE COULD PROVIDE "PATCH TEST KIT¿. THIS REPORT IS FOR ONE (1)5.5 EXP VERSE FEN SCR 6.0X55. THIS IS REPORT 6 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 17939976 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SALES REP WAS CONTACTED BY SURGEON¿S OFFICE STAFF ON 9/27/2023 REQUESTING THE METAL COMPOSITION FOR IMPLANTS USED ON A PATIENT . HE EMAILED SURGEON AND HIS STAFF DIRECTLY AFTER BEING CONTACTED. HE PROVIDED THEM WITH THE REQUESTED INFORMATION FOR EXPEDIUM AND METAL COMPOSITION BREAKDOWNS. THEY SAID THE PATIENT WAS EXPERIENCING SWELLING, REDNESS AND IRRITATION IN HIS ABDOMEN. POTENTIALLY MAY BE HAVING A REACTION TO THE IMPLANTS. HE WAS CONTACTED AGAIN BY SURGEON¿S OFFICE THIS AFTERNOON. THE PATIENT WAS REFERRED TO A DERMATOLOGIST AND SURGEON¿S OFFICE ASKED IF WE COULD PROVIDE "PATCH TEST KIT¿. THIS REPORT IS FOR ONE (1)5.5 EXP VERSE FEN SCR 6.0X55. THIS IS REPORT 5 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 17939968 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SALES REP WAS CONTACTED BY SURGEON¿S OFFICE STAFF ON (B)(6) /2023 REQUESTING THE METAL COMPOSITION FOR IMPLANTS USED ON A PATIENT . HE EMAILED SURGEON AND HIS STAFF DIRECTLY AFTER BEING CONTACTED. HE PROVIDED THEM WITH THE REQUESTED INFORMATION FOR EXPEDIUM AND METAL COMPOSITION BREAKDOWNS. THEY SAID THE PATIENT WAS EXPERIENCING SWELLING, REDNESS AND IRRITATION IN HIS ABDOMEN. POTENTIALLY MAY BE HAVING A REACTION TO THE IMPLANTS. HE WAS CONTACTED AGAIN BY SURGEON¿S OFFICE THIS AFTERNOON. THE PATIENT WAS REFERRED TO A DERMATOLOGIST AND SURGEON¿S OFFICE ASKED IF WE COULD PROVIDE "PATCH TEST KIT¿. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X55 THIS IS REPORT 4 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 17939966 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SALES REP WAS CONTACTED BY SURGEON¿S OFFICE STAFF ON 9/27/2023 REQUESTING THE METAL COMPOSITION FOR IMPLANTS USED ON A PATIENT . HE EMAILED SURGEON AND HIS STAFF DIRECTLY AFTER BEING CONTACTED. HE PROVIDED THEM WITH THE REQUESTED INFORMATION FOR EXPEDIUM AND METAL COMPOSITION BREAKDOWNS. THEY SAID THE PATIENT WAS EXPERIENCING SWELLING, REDNESS AND IRRITATION IN HIS ABDOMEN. POTENTIALLY MAY BE HAVING A REACTION TO THE IMPLANTS. HE WAS CONTACTED AGAIN BY SURGEON¿S OFFICE THIS AFTERNOON. THE PATIENT WAS REFERRED TO A DERMATOLOGIST AND SURGEON¿S OFFICE ASKED IF WE COULD PROVIDE "PATCH TEST KIT¿. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X55. THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 17939932 ↗
• MalfunctionJul 22, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED DURING A POSTERIOR SPINAL FUSION (L5) PERFORMED ON (B)(6)2022, CROSS-THREADING OCCURRED DURING SETSCREW TIGHTENING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REPLACEMENT WHICH RESULTED IN 30-MINUTE SURGICAL DELAY. THE PATIENT WAS X-RAYED, AND IT WAS CONFIRMED THAT NO FRAGMENT HAD BEEN LEFT IN THE LESION. PATIENT WAS LISTED AS STABLE. THIS IS REPORT 1 OF 1 FOR PC-(B)(4). THIS REPORT IS FOR A POLYAXIAL SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15084116 ↗