EXPEDIUM 299704960Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034467023), received between Jul 24, 2018 and Jan 31, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionJan 31, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HOSPITAL RECEIVED CONTAMINATED INSTRUMENTS. THIS WAS NOTICED DURING FIELD INSPECTION/STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 6MM DOUBLE-LEAD TAP, CAN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614013 ↗
• MalfunctionAug 28, 2023No Apparent Adverse Event; No Apparent Adverse Event

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE TAPS WERE RECEIVED IN LOAN SET. NO ADVERSE EVENT. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM DOUBLE-LEAD TAP, CANNULATED 6MM 30-60MM PLUS OR MINUS 1.67 PERCENT. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17638597 ↗
• InjuryJun 1, 2023Break; Entrapment of Device; Break; Entrapment of Device

  THE SURGERY WAS DELAYED FOR AN HOUR DUE TO THE REPORTED EVENT. THERE WERE NO ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE THE TAP BROKE INSIDE THE IS JOINT, WHERE A FUSION WAS PLANNED INITIALLY AND WAS PERFORMED AFTERWARDS, BUT AT A DIFFERENT AND MORE SEVERE ANGLE. THERE WAS OTHER MEDICAL INTERVENTION BECAUSE MORE X-RAYS HAD TO BE PERFORMED AND THE TRAJECTORY HAD TO BE COMPLETELY NEW FOR A PATIENT WITH SEVERE PELVIC DYSGENESIS. FOR THE PATIENT'S STATUS AND OUTCOME, NO OUTCOME DISABILITIES HAVE OCCURRED DUE TO THE FUSION OF THE IS JOINT IN ANOTHER ANGLE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037862 ↗
• MalfunctionDec 15, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2021 DURING AN UNKNOWN PROCEDURE, THE SURGEON WAS TAPPING TOUGH SCLEROTIC BONE OVER THE GUIDEWIRE. BOTH VERSE CANNULATED TAPS SNAPPED WHEN PREPARING THE PILOT HOLE. FRAGMENTS WERE GENERATED AND REMOVED USING DOLPHIN NOSED PLIERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ALTERNATIVE TAP. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM DOUBLE-LEAD TAP, CANNULATED 6MM 30-60MM PLUS OR MINUS 1.67 PERCENT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010111 ↗
• MalfunctionJul 24, 2018Break; Break

  REVISION PROCEDURE TO RESTORE LORDOSIS. DR. (B)(6), (B)(6) HOSPITAL, (B)(6) 2018. INSTRUMENT ISSUE OCCURRED DURING A REVISION SURGERY. THE PATIENT HAD VERY SCLEROTIC BONE. A PORTION OF THE INSTRUMENT BROKE OFF AND WAS NOT ABLE TO BE RETRIEVED. IT REMAINS DEEP IN THE ILIUM. THE SURGEON IS NOT CONCERNED AND DOES NOT FEEL THAT THE FRAGMENT WILL MIGRATE. THE REMAINING PORTION OF THE INSTRUMENT IS AVAILABLE FOR RETURN. NO X-RAY IMAGES ARE AVAILABLE. (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7713349 ↗