NA 04.033.170SRecalls & reported problems
Synthes GmbH · 11MM / TI CANN FRN / GT 400MM / RIGHT - STERILE · Class 2 · Implant
Data updated Oct 16, 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 10886982271617), received between Feb 12, 2020 and Feb 12, 2020 — classified as 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF ONE (1) FEMORAL RECONSTRUCTION NAIL, ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE (LCP) CURVED CONDYLAR PLATE, TWO (2) PROXIMAL LOCKING SCREW, TWO (2) DISTAL LOCKING SCREW AND TEN (10) UNKNOWN SCREWS DUE TO POSSIBLE INFECTION. THE PATIENT STATUS AND PROCEDURE OUTCOMES ARE UNKNOWN. THIS IS REPORT 01 OF 06 OF (B)(4).
Patient problems: Unspecified Infection
MAUDE report 9700111 ↗
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- PRECICE® Intramedullary Limb Lengthening System LSC5-050Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- PRECICE Intramedullary Limb Lengthening System LSB5-075Nuvasive 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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