EXPEDIUM 179799645Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034083650), received between Jul 26, 2017 and Sep 11, 2018 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE FOLLOWING WAS REPORTED: REVISION: DR. (B)(6); (B)(6) 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 7865544 ↗
• InjurySep 11, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE FOLLOWING WAS REPORTED: REVISION: DR. (B)(6); (B)(6) 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 (B)(6).

  Patient problems: Spinal Column Injury

  MAUDE report 7865409 ↗
• InjurySep 11, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE FOLLOWING WAS REPORTED: REVISION: DR. (B)(6) 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)(4).

  Patient problems: Spinal Column Injury

  MAUDE report 7865139 ↗
• InjurySep 11, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE FOLLOWING WAS REPORTED: REVISION: DR. (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 7864297 ↗
• MalfunctionJul 26, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE SCREW HAD TO BE EXPLANTED DURING REVISION SURGERY. WHEN THE SURGEON TRIED TO ALIGN THE HEAD OF THE SCREW WITH THE HEAD ADJUSTER THE INNER PARTS OF THE SCREW HEAD GOT LOOSE AND IT MADE GREAT DIFFICULTIES TO REMOVE THE SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6745004 ↗