SPATIAL FRAME 71070364Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00885556119181), received between Feb 24, 2020 and Feb 28, 2022 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2022Break; Break

  IT WAS REPORTED THAT THE EQUATOR CLAMP BROKE IN HALF. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13625561 ↗
• MalfunctionFeb 9, 2022Break; Break

  IT WAS REPORTED THAT THE EQUATOR CLAMP WAS BROKEN. SINCE THIS WAS NOTICED DURING A FIELD INSPECTION, NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13500032 ↗
• MalfunctionNov 17, 2021Break; Solder Joint Fracture; Break; Solder Joint Fracture

  IT WAS REPORTED THAT A EQUATOR CLAMP WAS FOUND TO BE BROKEN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12830783 ↗
• MalfunctionAug 9, 2021Break; Break

  IT WAS REPORTED THAT A WIRE CUTTER HAVE WEAR AND DAMAGE AND A EQUATOR CLAMP IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297599 ↗
• MalfunctionJul 13, 2021Break; Break

  IT WAS REPORTED THAT AN EQUATOR CLAMP WAS FOUND TO BE BROKEN INSIDE THE PACKAGE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159254 ↗
• MalfunctionJun 23, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN EXTERNAL FIXATION SURGERY, THE KNOB TO TIGHTEN AN EQUATOR CLAMP BROKE OFF WHILE INSTRUMENTS WERE OUTSIDE THE PATIENT. THE SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053811 ↗
• MalfunctionSep 30, 2020Break; Break

  IT WAS REPORTED THAT WAS WHILE PREPARING THE INSTRUMENTATION ON THE BACK TABLE BEFORE THE CASE STARTED THE EQUATOR CLAMP BROKE. PATIENT NOT INJURED. DELAY REPORTED LESS OR EQUAL THAN 30 MINUTES. S+N BACK-UP DEVICE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10609699 ↗
• MalfunctionSep 11, 2020Break; Break

  IT WAS REPORTED THAT THE PLASTIC PIECE THAT HOLDS THE METAL PIN BROKE OFF. NO INJURY, NO DELAY, S & N BACKUP AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10521937 ↗
• MalfunctionJun 29, 2020Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS FOUND BROKEN. IT IS UNKNOWN WHEN THIS HAPPEN OR IF THERE WAS A CASE INVOLVED. NO INJURY REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10209745 ↗
• MalfunctionJun 6, 2020Break; Break

  IT WAS REPORTED THAT THE EQUATOR CLAMP BROKE WHILE BEING CLEANED AFTER PROCEDURE. NO BACKUP DEVICE WAS REQUIRED AND NO SURGICAL DELAY REPORTED SINCE THE PROCEDURE WAS ALREADY FINISHED AS INTENDED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10126560 ↗
• MalfunctionFeb 24, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE EQUATOR CLAMP WAS FOUND BROKEN IN THE SET, SO REGULAR BOLT WAS USED TO SERVE ITS FUNCTION (WHICH IS NOT INTENDED FOR THIS REASON). THERE WERE NO DELAYS IN THE PROCEDURE AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9747266 ↗
• MalfunctionFeb 24, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE EQUATOR CLAMP WAS FOUND BROKEN IN THE SET, SO REGULAR BOLT WAS USED TO SERVE ITS FUNCTION (WHICH IS NOT INTENDED FOR THIS REASON). THERE WERE NO DELAYS IN THE PROCEDURE AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9747259 ↗
• MalfunctionFeb 24, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE EQUATOR CLAMP WAS FOUND BROKEN IN THE SET, SO REGULAR BOLT WAS USED TO SERVE ITS FUNCTION (WHICH IS NOT INTENDED FOR THIS REASON). THERE WERE NO DELAYS IN THE PROCEDURE AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9747255 ↗

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