SPATIAL FRAME 71071307XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556119136), received between Jul 6, 2017 and Jul 6, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

1 other recall cover devices cleared under the same FDA submission (K093047); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2017Fracture; Fracture

  IT WAS REPORTED THAT DURING THE CORRECTION PERIOD WITH TSF PRODUCTS, THE K-PIN BROKE AND THERE IS LOOSENING BETWEEN THE CONNECTION PART OF NAIL AND THE RING.

  Patient problems: No Information

  MAUDE report 6691891 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093047. One submission often covers many models, so check the product and lot details in each record.

• Z-0245-2022 · Jun 17, 2021 · Open, Classified
  Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434