SPATIAL FRAME 71070490Recalls & reported problems
Smith & Nephew, Inc. · STERILIZATION TRAY FOR SPATIAL FRAME RINGS · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010462350), received between Dec 29, 2020 and Dec 29, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Device Reprocessing Problem” (1 report).
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
Device problems
- Device Reprocessing Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 29, 2020Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THAT THERE WAS DRIED BLOOD ON THE TRAY AND HARDWARE, EVEN THOUGH IT WAS STERILISED UPON ARRIVAL FROM LOAN. THE CASE ABANDONED MID SURGERY DUE TO CONTAMINATION RISK. IT IS UNKNOWN WHETHER THE SURGERY WAS RESCHEDULED OR NOT. PATIENT OUTCOME IS ALSO UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11086844 ↗
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- n.a. 39501CECKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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