EXPEDIUM 279702600Recalls & reported problems
Depuy Spine, LLC · EXPEDIUM SPINE SYSTEM DOUBLE-LEAD TAP 6.0mm 30-60mm Plus or Minus 1.33 Percent · Class 1
All models of EXPEDIUM (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034198637), received between Jan 23, 2018 and Dec 5, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (7 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.
Reports received per month
Most reported problems
Device problems
- Break7
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2025Break; Break
IT WAS REPORTED ON AN UNKNOWN DATE THAT TAP BROKE WHILE IN USE, SNAPPED IN HALF. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information
MAUDE report 23729890 ↗MalfunctionDec 5, 2025Break; Break
IT WAS REPORTED ON AN UNKNOWN DATE THAT TAP BROKE WHILE IN USE, SNAPPED IN HALF. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information
MAUDE report 23729526 ↗MalfunctionJun 17, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, THE TAP TIP BROKE OFF, THE BROKEN PIECE WAS REMOVED. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM DOUBLE-LEAD TAP 6.0MM 30-60MM PLUS OR MINUS 1.33 PERCENT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19548929 ↗MalfunctionNov 28, 2022Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TAP BROKE OFF. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM DOUBLE-LEAD TAP 6.0MM 30-60MM PLUS OR MINUS 1.33 PERCENT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15869188 ↗MalfunctionOct 18, 2022Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TAP WAS BROKEN. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM DOUBLE-LEAD TAP 6.0MM 30-60MM PLUS OR MINUS 1.33 PERCENT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15625047 ↗MalfunctionOct 25, 2019Break; Break
LIBERTAS: IT WAS REPORTED THAT ON (B)(6) 2019, THE 6MM DUAL-LEAD TAP WAS FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9240518 ↗MalfunctionJan 23, 2018Break; Break
SURGEON WAS TAPPING A PREPARED SCREW HOLE AT L4 ON THE PATIENT'S LEFT. WHEN THE SURGEON DROPPED HIS HAND TO IMPROVE TRAJECTORY THE TAP SHEARED OFF AT THE POINT OF THE SHAFT WHERE THE LARGER DIAMETER TRANSITIONS TO A SMALLER DIAMETER SHAFT. THE TAP REMAINED IN THE PATIENT BONE UNTIL THE SURGEON REMOVED THE REMAINING PORTION OF THE TAP WITH A PAIR OF PLIERS. PATIENT CONSEQUENCE? NO. ACTION TAKEN FOR PROCEDURE: REMOVAL OF INSTRUMENT WITH PLIERS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7213503 ↗
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
- NA 03.424.126Synthes GmbH · TAP, BONE1 recall0 reports
- A.L.P.S.® 8241-50-170Biomet Orthopedics, LLC · TAP, BONE1 recall0 reports
- N/A 876-474Medtronic Sofamor Danek, Inc. · 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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