SPATIAL FRAME 71070115XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556119556), received between Aug 9, 2017 and Feb 23, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A PATIENT WITH A SIGNIFICANT BONE DEFECT ON RIGHT TIBIA UNDERWENT OSTEOTOMY AND BONE TRANSPORT TREATMENT WITH A TSF (TAYLOR SPATIAL FRAME) EXTERNAL FIXATOR ON (B)(6) 2022. FOLLOWING THIS PROCEDURE, THE PATIENT SUSTAINED RIGHT TIBIA NONUNION THAT REQUIRED REPAIR WITH AUTOGRAFT FROM THE RIGHT DISTAL FEMUR ON (B)(6) 2022. AT THAT MOMENT, THE PLAN WAS TO TAKE THE PATIENT BACK TO THE OR IN SIX WEEKS TO DEFINITELY REMOVE THE FRAME. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21442302 ↗
• InjuryFeb 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A TAYLOR SPATIAL FRAME (TSF) EXTERNAL FIXATOR PLACEMENT ON (B)(6) 2018 AS PART OF AN EXTERNAL FIXATION REVISION SURGERY DUE TO INFECTION IN THE CALCANEAL PINS, THE PATIENT SUSTAINED NONUNION OF THE RIGHT TIBIA FRACTURE AND PERSISTENT DRAINING WOUND WITH SUSPECTED OSTEOMYELITIS IN OR AROUND (B)(6) 2018. IT IS UNKNOWN IF THE FRAME WAS REMOVED AND THE RLE AMPUTATED AS PER SURGEON'S RECOMMENDATION GIVEN THE PATIENT'S COMORBIDITIES AND RISK FOR SEPSIS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fluid Discharge; Nonunion/Delayed-union Bone Fracture

  MAUDE report 21441816 ↗
• InjuryAug 9, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION WILL BE DONE DUE TO PROXIMAL RING BEING BROKEN. SURGEON FOUND THE TIBIAL NON-UNION.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 6777790 ↗

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