EXPEDIUM 279702080Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034198477), received between Mar 21, 2022 and Sep 11, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Device Slipped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50742686 ↗
• MalfunctionApr 24, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE COMPRESSOR AND DISTRACTOR BROKE DURING CASE. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) XPDM DISTRACTOR, PARALLEL. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19175577 ↗
• MalfunctionOct 5, 2023Break; Break

  IT WAS REPORTED THAT ON SEPTEMBER 16, 2023, THE FACILITY NOTIFIED OF INSTRUMENTS THAT HAD BEEN BROKEN OR DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. ISSUES WERE DISCOVERED POSTOPERATIVELY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM DISTRACTOR, PARALLEL ACTION. THIS IS REPORT 4 OF 9 FOR (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17875182 ↗
• MalfunctionApr 25, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE EXPEDIUM DISTRACTOR BROKE AND THE SALES REP NEEDS A NEW ONE FOR CASES ON (B)(6) 2023. IT DID NOT BREAK IN SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) XPDM DISTRACTOR, PARALLEL THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806554 ↗
• MalfunctionFeb 15, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS DISCOVERED PREOPERATIVELY THAT THE DEVICES WERE BROKEN. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM DISTRACTOR, PARALLEL ACTION. THIS IS REPORT 9 OF 13 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16378169 ↗
• MalfunctionMar 21, 2022Device Slipped; Detachment of Device or Device Component; Device Slipped; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: CUSTOMER REPORTS THAT A SCREW LOOSENS ITSELF FROM THE INSTRUMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE XPDM DISTRACTOR, PARALLEL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13841333 ↗