SPATIAL FRAME 71070410Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010462336), received between May 8, 2019 and May 13, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Corroded” (3 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.

• MalfunctionMay 13, 2021Corroded; Corroded

  IT WAS REPORTED THAT DURING DELIVERY INSPECTION, IT WAS FOUND THAT THE TSF TORQUE WRENCH 10MM WAS RUSTY. AS THIS WAS FOUND DURING INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816886 ↗
• MalfunctionDec 29, 2020Corroded; Corroded

  IT WAS REPORTED THAT THERE IS RUST IN TWO TSF TORQUE WRENCH 10M. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11091793 ↗
• MalfunctionDec 29, 2020Corroded; Corroded

  IT WAS REPORTED THAT THERE IS RUST IN TWO TSF TORQUE WRENCH 10M. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11091792 ↗
• MalfunctionMay 8, 2019Break; Break

  IT WAS REPORTED THAT THE SOCKET ON THE WRENCH HAS BROKEN OFF. ITEM NO LONGER SUITABLE FOR SURGERY. NO HARM TO PATIENT, NO DELAY TO SURGERY. S&N BACKUP USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8593772 ↗

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