EXPEDIUM 179712635Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034067711), received between Oct 11, 2017 and Sep 24, 2019 — classified as 8 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 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.

• InjurySep 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT INITIATED COMPLAINT: IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A LAMINECTOMY OF T11-L3 DUE TO A FRACTURE AT L1 IS NOW SHOWING SYMPTOMS OF HYPERSENSITIVITY TO THE METAL INSTALLED IN HIS BACK DURING THE FUSION. REPORTEDLY, THE PATIENT IS ALLERGIC TO MOST OTHER METALS SUCH AS TITANIUM HARDWARE, BUT WITH HER SYMPTOMS, THIS SEEMS TO BE MOST LIKELY THE CAUSE. ADDITIONALLY, THE PATIENT WANTS TO OBTAIN A SAMPLE OF THE HARDWARE OR THE SAMPLE OF THE MATERIAL TO VERIFY IF THIS IS POSSIBLY WHAT'S CAUSING THE PROBLEMS. THE PATIENT CAN PROVIDE THE ACTUAL IMPLANT TRACKING SHEET FROM THE HOSPITAL IF NEEDED. THERE WAS NO INFORMATION OF THE SURGICAL DELAY AND PATIENT CONSEQUENCE IS UNKNOWN. THIS COMPLAINT INVOLVES ELEVEN (11) DEVICE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 9111021 ↗
• InjurySep 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT INITIATED COMPLAINT: IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A LAMINECTOMY OF T11-L3 DUE TO A FRACTURE AT L1 IS NOW SHOWING SYMPTOMS OF HYPERSENSITIVITY TO THE METAL INSTALLED IN HIS BACK DURING THE FUSION. REPORTEDLY, THE PATIENT IS ALLERGIC TO MOST OTHER METALS SUCH AS TITANIUM HARDWARE, BUT WITH HER SYMPTOMS, THIS SEEMS TO BE MOST LIKELY THE CAUSE. ADDITIONALLY, THE PATIENT WANTS TO OBTAIN A SAMPLE OF THE HARDWARE OR THE SAMPLE OF THE MATERIAL TO VERIFY IF THIS IS POSSIBLY WHAT'S CAUSING THE PROBLEMS. THE PATIENT CAN PROVIDE THE ACTUAL IMPLANT TRACKING SHEET FROM THE HOSPITAL IF NEEDED. THERE WAS NO INFORMATION OF THE SURGICAL DELAY AND PATIENT CONSEQUENCE IS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 9109349 ↗
• InjuryJun 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEVELOPED AN INFECTION THAT IS REQUIRING AN I&D AND POSSIBLE HARDWARE REMOVAL ON (B)(6) 2018. PATIENT CONSEQUENCE? UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: Unspecified Infection

  MAUDE report 7593298 ↗
• InjuryJun 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEVELOPED AN INFECTION THAT IS REQUIRING AN I&D AND POSSIBLE HARDWARE REMOVAL ON (B)(6) 2018. PATIENT CONSEQUENCE? UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: Unspecified Infection

  MAUDE report 7593200 ↗
• InjuryJun 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEVELOPED AN INFECTION THAT IS REQUIRING AN I&D AND POSSIBLE HARDWARE REMOVAL ON (B)(6) 2018 PATIENT CONSEQUENCE? UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: Unspecified Infection

  MAUDE report 7593158 ↗
• InjuryJun 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEVELOPED AN INFECTION THAT IS REQUIRING AN I AND D AND POSSIBLE HARDWARE REMOVAL ON (B)(6) 2018. PATIENT CONSEQUENCE? :UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Unspecified Infection

  MAUDE report 7593113 ↗
• InjuryOct 11, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  THIS IS A REVISION/EXTENSION POSTERIOR LUMBAR CASE. THE SURGEON IS REMOVING THE EXPEDIUM SCREWS AND RODS, EXTENDING THE FUSION AND REPLACING SCREWS WITH A NON-DEPUY SYNTHES SYSTEM.

  Patient problems: Failure of Implant; Injury

  MAUDE report 6941195 ↗
• InjuryOct 11, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  THIS IS A REVISION/EXTENSION POSTERIOR LUMBAR CASE. THE SURGEON IS REMOVING THE EXPEDIUM SCREWS AND RODS, EXTENDING THE FUSION AND REPLACING SCREWS WITH A NON-DEPUY SYNTHES SYSTEM.

  Patient problems: Failure of Implant; Injury

  MAUDE report 6940668 ↗