Speed Titan SE-1818TIRecalls & reported problems
Synthes GmbH · Speed TITAN 18x18x18mm 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810633021538), received between Apr 4, 2016 and Jun 20, 2018 — classified as 1 injury, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- Bone Fracture(s)1
- Failure of Implant1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 20, 2018Break; Break
IT WAS REPORTED THAT THE PATIENT HAD A POST-OPERATIVE VISIT ON OR ABOUT (B)(6) 2018, IT WAS FOUND THAT ONE OF THE TWO BIOMEDICAL ENTERPRISES STAPLE (BME STAPLE) WAS BROKEN. BME STAPLES WERE IMPLANTED ON AN UNKNOWN DATE. REVISION SURGERY WILL BE SCHEDULED. PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Failure of Implant
MAUDE report 7620226 ↗MalfunctionApr 4, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2015, PATIENT UNDERWENT FIXATION PROCEDURE WITHIN THE CALCANEAL CUBOID JOINT, USING A BME TITAN. AT ONE WEEK POST OPERATIVE, PATIENT RETURNED FOR FOLLOW UP APPOINTMENT AND X-RAY REVEALED THAT IMPLANT HAD BROKEN. DEVICE WAS REMOVED ON (B)(6) 2016.
Patient problems: Bone Fracture(s)
MAUDE report 5545475 ↗
Other Staple, Fixation, Bone devices
- N/A StandardSynthes GmbH · Staple, Fixation, Bone2 recalls16 reports
- GII QUICKANCHOR ETHIBOND 212034Medos International Sàrl · STAPLE, FIXATION, BONE98 reports
- 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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