SPATIAL FRAME 71070114XRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556119563), received between Mar 13, 2020 and Feb 22, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEVELOPED A LEFT ANKLE CHRONIC INFECTION AFTER PLACEMENT OF A COMPETITORS EXTERNAL FIXATOR ON (B)(6) 2019. HE UNDERWENT TAYLOR SPATIAL FRAME (TSF) EXTERNAL FIXATOR PLACEMENT WITH I&D AND ANTIBIOTIC THERAPY INITIATION. FOLLOWING THIS PROCEDURE, THE PATIENT RETURNED TO THE OR ON (B)(6) 2020 FOR REMOVAL OF THE TSF FIXATOR, WITH I&D AND ANTIBIOTIC BEADS PLACEMENT DUE TO SEPTIC NONUNION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21441845 ↗
• InjuryNov 4, 2020Break; Break

  IT WAS REPORTED THAT THE RING WAS IMPLANTED ON (B)(6) 2020. NOW THE RING IS BROKEN, BUT THE CONSTRUCTION IS STILL IN PLACE ON THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10788086 ↗
• InjuryOct 19, 2020Break; Break

  IT WAS REPORTED THAT THE FULL RING 155MM WAS IMPLANTED ON (B)(6) 2020 AND IT WAS NOTICED THAT NOW THE DEVICE IS BROKEN. THE CONSTRUCTION IS STILL IN PLACE ON THE PATIENT. NO INFORMATION ABOUT HOW THE ISSUE WILL BE RESOLVED OR PATIENT STATUS WAS INITIALLY GIVEN.

  Patient problems: Injury

  MAUDE report 10700813 ↗
• InjuryMar 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE RING BROKE 3 MONTHS AFTER BEING IMPLANTED ON THE PATIENT. AFTER THE FRACTURE WAS DETECTED, THE DEFECTIVE RING WAS STABILIZED WITH AN ADDITIONAL RING. THE SURGEON KEEPS THE CONSTRUCTION IN PLACE ON THE PATIENT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 9831311 ↗

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