NA 1896-5052SRecalls & reported problems
Stryker GmbH · Locking Screw, Fully Threaded · 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 04546540382368), received between Oct 26, 2018 and Feb 23, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Fracture” (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
- Fracture2
- Patient-Device Incompatibility1
Patient problems
- Failure of Implant1
- Injury1
- Insufficient Information1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 23, 2026Fracture
IT WAS REPORTED THAT THE IMPLANTATION TOOK PLACE ON (B)(6) 2023 WITHOUT PROBLEMS. IN (B)(6) 2023, A NAIL FRACTURE OCCURRED DURING REHAB. ON 01/27/2026 - UPON PRODUCT RETURN AND INITIAL INSPECTION, TWO BROKEN SCREWS WERE NOTICED.
Patient problems: Insufficient Information
MAUDE report 24421123 ↗InjuryJul 27, 2020Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT'S RIGHT FEMUR WAS REVISED DUE TO THE NAIL BREAKING AT THE JUNCTION OF THE LAG SCREW, WHICH THEN LED TO TWO DISTAL SCREWS BREAKING. REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant; Injury
MAUDE report 10329712 ↗InjuryOct 26, 2018Patient-Device Incompatibility
IT WAS REPORTED THAT THE PATIENT'S RIGHT TIBIA WAS REVISED DUE TO SUSPICION OF INFECTION AFTER PATIENT PRESENTED WITH PUS AT THE IMPLANT SITE. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.
Patient problems: Unspecified Infection
MAUDE report 8010645 ↗
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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