EXPEDIUM 179799640Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034083643), received between Sep 11, 2018 and Mar 5, 2020 — classified as 4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2020No Apparent Adverse Event; No Apparent Adverse Event

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THAT PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION AND SEPSIS LEADING TO CAGE BECOMING DISLODGED. SURGEON REMOVED POSTERIOR INSTRUMENTATION, INSERTED ALIF CAGES AND PUT NEW METALWORK IN POSTERIORLY IN THIRD STAGE OPERATION. ALL SCREWS WERE REMOVED AND BIOPSIES TAKEN OF THE PEDICLES. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 X 6 X 40MM. THIS IS REPORT 1 OF 6 FOR (B)(4). THIS (B)(4) WILL CAPTURE THE POST-OP EVENT ( REVISION WAS DUE PREVIOUS INFECTION AND SEPSIS LEADING TO CAGE BECOMING DISLODGED), WHILE (B)(4) WILL CAPTURE THE INTRA-OP EVENT (DIFFICULTY REMOVING THE S1 SCREW).

  Patient problems: Unspecified Infection

  MAUDE report 9792707 ↗
• InjurySep 24, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT CUSTOMER SERVICE WAS CONTACTED BY A PATIENT THAT ASKED WHICH MATERIALS THE IMPLANTS ARE MADE OF. THE PATIENT HAD SPINE SURGERY IN (B)(6) 2017. ON 30AUG2018: PER ADDITIONAL INFORMATION FROM LOC, SUSPECTED ALLERGIC REACTION TO EXPEDIUM SCREWS (LUMBAR). THE PATIENT NEEDS TO KNOW WHAT METALS COMPOUND THE TITANIUM ALLOY .

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 7902944 ↗
• InjurySep 11, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE FOLLOWING WAS REPORTED: REVISION: DR. (B)(6); (B)(6) PRIVATE HOSPITAL (B)(6) 2018. PATIENT HAS DEMENTIA WHICH HAS ESCALATED SINCE PRIMARY SURGERY DATED (B)(6) 2018. THE DEMENTIA HAS LEAD TO POOR DIET AIDING IN A PSEUDOARTHROSIS (NON-FUSION). A RECENT FALL THEN LOOSENED THE PRE EXISTING CONSTRUCT. PRIMARY SCREWS REMOVED AND REPLACED WITH NEW SCREWS FOR NEW FIXATION. FEMALE PATIENT INITIALS (B)(6).

  Patient problems: Spinal Column Injury

  MAUDE report 7865052 ↗
• InjurySep 11, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE FOLLOWING WAS REPORTED: REVISION: (B)(6). PATIENT HAS DEMENTIA WHICH HAS ESCALATED SINCE PRIMARY SURGERY DATED (B)(6) 2018. THE DEMENTIA HAS LEAD TO POOR DIET AIDING IN A PSEUDOARTHROSIS (NON-FUSION). A RECENT FALL THEN LOOSENED THE PRE EXISTING CONSTRUCT. PRIMARY SCREWS REMOVED AND REPLACED WITH NEW SCREWS FOR NEW FIXATION. FEMALE PATIENT INITIALS (B)(6).

  Patient problems: Spinal Column Injury

  MAUDE report 7864239 ↗