NA 1895-5085SRecalls & reported problems
Stryker GmbH · Condyle Screw · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540202208), received between Sep 15, 2023 and May 5, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Fracture” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Break1
Patient problems
- Nonunion/Delayed-union Bone Fracture2
- Failure of Implant1
- Impaired Healing1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 5, 2026Fracture
IT WAS REPORTED THAT TWO CONDYLE SCREWS AND ONE ADVANCED LOCKING SCREW BROKE. THERE WERE ADDITIONAL REPORTS OF A NON-UNION. THIS RESULTED IN A REVISION SURGERY.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 25079103 ↗InjuryFeb 24, 2026Fracture
AS REPORTED: "BOLTS BROKE IN PATIENT LEG REVISION WAS NEEDED, THE SURGEON HAD TO DO ANOTHER SURGERY"
Patient problems: Nonunion/Delayed-union Bone Fracture; Pain
MAUDE report 24430917 ↗InjurySep 15, 2023Break; Fracture; Break; Fracture
AS REPORTED: "T2 ALPHA FEMORAL RETROGRADE NAIL WAS FRACTURED AND DISTAL SCREWS WERE FRACTURED. ADVERSE CONSEQUENCES OF DELAYED FUSION AND REVISION SURGERY WERE REPORTED TOO."
Patient problems: Failure of Implant; Impaired Healing
MAUDE report 17760196 ↗
Other ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices
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- NA 03.037.026Synthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES225 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls2 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-045Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- PRECICE® Intramedullary Limb Lengthening System LSC5-050Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
- PRECICE Intramedullary Limb Lengthening System LSB5-040Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls0 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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