NA 1895-5065SRecalls & 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 04546540202161), received between Jun 28, 2018 and May 5, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Fracture2
Patient problems
- Failure of Implant1
- Impaired Healing1
- No Code Available1
- Nonunion/Delayed-union Bone Fracture1
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 25078878 ↗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 17760199 ↗InjuryJun 28, 2018Break
IT WAS REPORTED THAT AFTER THE FIRST REVISION SURGERY((B)(6) 2018), BREAKAGE OF THE SCREW WHICH WAS REPLACED IN THE REVISION SURGERY AND MOST PROXIMAL CONDYLAR SCREW WERE FOUND ON (B)(6) 2018. REVISION REPORTED UNDER PI (B)(4). SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 AND BREAKAGE OF THE ALL OF IMPLANTED SCREWS WERE FOUND DURING THE REVISION SURGERY. IN THE SECOND REVISION SURGERY, ALL OF THE IMPLANTS INCLUDING THE NAIL WERE REPLACED.
Patient problems: No Code Available
MAUDE report 7648504 ↗
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- 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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