EXPEDIUM 299704950Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM DOUBLE-LEAD TAP, CANNULATED 5mm 30-60mm Plus or Minus 1.67 Percent · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034466989), received between Dec 15, 2021 and Dec 15, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 5MM 30-60MM PLUS OR MINUS 1.67 PERCENT. THIS IS REPORT 2 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13010442 ↗
Other TAP, BONE devices
- NA 311.43Synthes GmbH · TAP, BONE176 reports
- NA 311.01Synthes GmbH · TAP, BONE106 reports
- NA 311.431Synthes GmbH · TAP, BONE70 reports
- NA 03.424.124Synthes GmbH · TAP, BONE1 recall7 reports
- N/A 876-474Medtronic Sofamor Danek, Inc. · TAP, BONE1 recall0 reports
- NA 03.424.126Synthes GmbH · TAP, BONE1 recall0 reports
- A.L.P.S.® 8241-50-170Biomet Orthopedics, LLC · TAP, BONE1 recall0 reports
- NA 311.44Synthes GmbH · TAP, BONE41 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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