TAYLOR SPATIAL FRAME 71070286Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20885556119376), received between Dec 14, 2023 and Dec 14, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING AN EXTERNAL FIXATION SURGERY, A DIFFERENCE BETWEEN THE METAL STRENGTH OF A THICK ITALIAN NUT AND THE 10MM WRENCHES WAS NOTICED; OR THAT THE 10MM WRENCH MIGHT BE SLIGHTLY TOO LARGE FOR THE NUT. THIS RESULTED IN DEFORMING THE NUTS UPON TIGHTENING, AND BURRING THE WRENCHES. AS A CONSEQUENCE, A WRENCH 10MM FLEX HEAD WAS STRICKEN WITH A MALLET, WHICH INADVERTENTLY MALIGNED THE FRAME. ALL THE FIXATION (4 HA PINS) HAD TO BE REMOVED AND RESTARTED, ADDING AT LEAST 1 HOUR TO THE PROCEDURE AND ADDITIONAL HOLES AND INCISIONS TO THE BONE HAD TO BE PERFORMED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Perforation

  MAUDE report 18331872 ↗

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