Speed Titan SE-2015TIRecalls & reported problems
Synthes GmbH · Speed TITAN 20x15x15mm Implant Kit · Class 2 · Implant
All models of Speed Titan (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810633021552), received between Mar 25, 2022 and Mar 25, 2022 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 25, 2022Break; Break
IT WAS REPORTED THAT ON (B)(6) 2022 ONE OF THE LEGS OF A DRILLING GUIDE FOR A SPEED TITAN BROKE OFF DURING DRILLING. AN ADDITIONAL INCISION HAD TO BE MADE TO RETRIEVE THE BROKEN GUIDE WHICH TOOK ROUGHLY FIFTEEN(15)MIN AT THE END OF THE CASE. THIS REPORT IS FOR ONE (1) SPEEDTITAN COMPRESSION IMPL KIT 20X15X15. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Unspecified Tissue Injury
MAUDE report 13903362 ↗
Other Staple, Fixation, Bone devices
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- GII QUICKANCHOR ORTHOCORD 222983Medos International Sàrl · STAPLE, FIXATION, BONE94 reports
- Speed SE-0910Synthes GmbH · Staple, Fixation, Bone1 recall24 reports
- Speed Shift SE-2020-10Synthes GmbH · Staple, Fixation, Bone1 recall10 reports
- Lapiplasty SpeedPlate SK50Treace Medical Concepts, Inc. · Staple, Fixation, Bone59 reports
- Speed SE-1512Synthes GmbH · Staple, Fixation, Bone1 recall6 reports
- LUPINE ORTHOCORD 210709Depuy Mitek, LLC · STAPLE, FIXATION, BONE56 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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