MODULAR RAIL SYSTEM 71933931Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556065334), received between Jul 3, 2018 and Nov 16, 2020 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 2020Break; Break

  IT WAS REPORTED THAT A SMALL RAIL SYSTEM WAS APPLIED TO A TIBIAL NON-UNION ON (B)(6) 2020. THERE WAS TWO SEGMENTS AND THREE 6MM PINS IN EACH SEGMENT. AFTER 12 DAYS THE RAIL BROKE. THE PATIENT RECEIVED A REVISION SURGERY AND DEVICE WAS EXCHANGED TO A LARGE MODULAR RAIL. NO ADDITIONAL INFORMATION PROVIDED. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10844665 ↗
• InjuryNov 20, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT RAIL HAS BENT, PREVENTING COMPLETE LENGTHENING TO OCCUR AND CAUSING THE PATIENT TO FALL INTO A VARUS DEFORMITY.

  Patient problems: Injury

  MAUDE report 8091281 ↗
• InjuryJul 3, 2018Break; Break

  RAIL HAS SNAPPED, SO FRACTURE NO LONGER REDUCED OR HEALED.

  Patient problems: Bone Fracture(s)

  MAUDE report 7657631 ↗