EXPEDIUM 299704110Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034467344), received between Feb 3, 2021 and Mar 28, 2024 — classified as 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2024Break; Material Discolored; Break; Material Discolored

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON AN UNKNOWN DATE. ON (B)(6) 2024, THE SALES REP WAS INFORMED THE FOLLOWINGS. IN THE SURGERY, IT WAS POINTED OUT THAT THE SCALES WHICH PRINTED ON THE TIP OF THE PEDICLE PROBE IN QUESTION WAS PEELING OFF, MAKING IT DIFFICULT TO SEE DURING THE SURGERY AND INTERFERING WITH SCREWING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE IS NO IMPACT ON THE PATIENT. THE PRODUCT IS A FREQUENTLY USED INSTRUMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) THORACIC PEDICLE PROBE, CRV. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18993835 ↗
• MalfunctionNov 10, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A TLIF (L5) FOR HERNIA ON (B)(6) 2022. DURING SCREW INSERTION FOR POSTERIOR FUSION, THE THORACIC PEDICLE PROBE GOT BROKEN. THE PATIENT¿S HARD BONE QUALITY ALSO AFFECTED BREAKAGE. AFTER BREAKAGE, THE PROBE WAS STUCK IN THE BONE, AND IT WAS REMOVED BY PLIERS. THERE WAS NO BROKEN FRAGMENT IN THE BONE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT CONSEQUENCES? NO. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) THORACIC PEDICLE PROBE, CRV. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15771872 ↗
• MalfunctionAug 3, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ONE KEY SHAFT WITH THE START TIP, THE OTHER TWO ARE WORN. NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1) THORACIC PEDICLE PROBE, CRV. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15156068 ↗
• MalfunctionFeb 3, 2021Break; Break

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT FRAGMENTED DURING THE PROCEDURE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT HARM/CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11274839 ↗