TAYLOR SPATIAL FRAME 71070343Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556119358), received between Jun 18, 2020 and Feb 24, 2021 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (5 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A REVISION OF A TAYLOR SPATIAL FRAME, THE BOLT ON THE BAR CLAMP WOULDN'T SUFFICIENTLY TIGHTEN. THE REVISION WAS NOT AS A RESULT OF THE ISSUE WITH THE BOLT. THERE WAS A CHANGE IN SURGICAL TECHNIQUE DUE TO THIS MALFUNCTION, THE SURGEON USED A CONNECTION PLATE AND THREADED ROD TO STABILIZE THE FRAME. NO DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11371562 ↗
• MalfunctionFeb 17, 2021Mechanical Jam

  IT WAS REPORTED THAT, THE FRAME STABILIZER TOOLS (B)(6) ARE NO LONGER ADJUSTABLE. THE BALL JOINT ON THE TWO CLAMPS NO LONGER MOVES, SO THEY CAN NO LONGER BE USED TO DO STRUT ADJUSTMENTS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11338305 ↗
• MalfunctionFeb 17, 2021Mechanical Jam

  IT WAS REPORTED THAT, THE FRAME STABILIZER TOOLS (B)(6) ARE NO LONGER ADJUSTABLE. THE BALL JOINT ON THE TWO CLAMPS NO LONGER MOVES, SO THEY CAN NO LONGER BE USED TO DO STRUT ADJUSTMENTS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11338301 ↗
• MalfunctionNov 12, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE 10MM NUT IS CROSS THREADED ON THE FRAME STABILIZATION CLAMP. NO CASE OR PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10832739 ↗
• MalfunctionJun 19, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT TWO FRAME STABILIZER TOOLS ARE LOCKED. AS NOTICED UPON INSPECTION, NO CASE WAS INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10173060 ↗
• MalfunctionJun 18, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT FRAME STABILIZER TOOL IS LOCKED. AS NOTICED UPON INSPECTION, NO CASE WAS INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10167100 ↗

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