Tornier Flex MWF108Recalls & reported problems
Tornier · Head Distractor · Class 1
All models of Tornier Flex (15)
Data updated Oct 16, 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 03700386974960), received between May 11, 2017 and May 11, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
WHILE TRYING TO REMOVE THE REVERSE TRAY THE HANDLE BROKE OFF. DURING SURGERY, THE FORK PART COLD WELDED IN BETWEEN THE TRAY AND STEM AND COULD NOT BE REMOVED. IT RESULTED IN HAVING TO REMOVE THE STEM AND CEMENTING A SMALLER STEM. DOWNSIZED IMPLANT AND CEMENTED. BACK UP DEVICE WAS AVAILABLE. EXTENDED SURGERY TIME GREATER THAN 30 MINUTES. TRAUMA OCCURRED AND CAUSED ADDITIONAL FRACTURE AND BONE LOSS.
Patient problems: Patient Problem/Medical Problem
MAUDE report 6560266 ↗
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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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