NCB® 02.02264.118Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024292918), received between Aug 7, 2019 and Aug 6, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (6 reports).

2 other recalls cover devices cleared under the same FDA submission (K100111); they may or may not involve this specific model.

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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT PATIENT HAD A FRACTURE OF THE OSTEOSYNTHESIS PLATE WHEN WALKING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 19919333 ↗
• InjuryJun 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED PATIENT UNDERWENT A REVISION POST IMPLANTATION DUE TO FATIGUE FAILURE OF DISTAL NCB PLATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 19557400 ↗
• InjuryApr 4, 2024Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 19042350 ↗
• InjuryJan 9, 2023Fracture; Fracture

  IT WAS REPORTED, THAT: THE PATIENT UNDERWENT A REVISION OF THE LEFT HIP DUE TO IMPLANT FRACTURE, APPROXIMATELY THREE (3) MONTHS POST-OP. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE, NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 16120753 ↗
• InjurySep 12, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT TWO MONTHS AFTER IMPLANTATION, THE FEMORAL PLATE FRACTURED. NO FURTHER OUTCOME WAS REPORTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15399212 ↗
• InjuryOct 8, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY IS PLANNED FOLLOWING A PLATE FRACTURE OCCURRED AT HOME.

  Patient problems: Failure of Implant

  MAUDE report 9165242 ↗
• InjuryAug 7, 2019Fracture; Fracture

  NO CHANGE TO PREVIOUSLY REPORTED EVENT.

  Patient problems: Failure of Implant

  MAUDE report 8869975 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100111. One submission often covers many models, so check the product and lot details in each record.

• Z-0304-2020 · Oct 10, 2019 · Terminated
  NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263009 0202263012 0202263015 0202263018 0202263021 0202263109 0202263112 0202263115 0202263118 0202263121
• Z-0329-2020 · Oct 10, 2019 · Terminated
  Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bits, manual surgical instruments for general use. Item Nos. 020