NA 7211097Recalls & reported problems
Smith & Nephew, Inc. · ADAPTER RAIL CLAMP(2 UNITS)TENET 7403 · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 23596010538615), received between Jan 13, 2021 and Jan 13, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Deformation1
- Unstable1
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.
MalfunctionJan 13, 2021Unstable; Material Deformation; Unstable; Material Deformation
IT WAS REPORTED THAT, DURING SURGERY, THE CRAMP SCREW THREAD WAS WAVY AND DUG. THUS, THE CRAMP WAS LOCKED AND THE "T-MAX" COULD NOT BE FIXED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11159533 ↗
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- NA 210080Mako Surgical Corp. · Operating Room Accessories Table Tray74 reports
- ALLEN 104002Hill-Rom, Inc. · Operating Room Accessories Table Tray1 recall8 reports
- N/A 7210569Smith & Nephew, Inc. · Accessories, operating-room, table (kit)57 reports
- ALLEN 107004Hill-Rom, Inc. · Operating Room Accessories Table Tray1 recall5 reports
- ALLEN 108001Hill-Rom, Inc. · Operating Room Accessories Table Tray1 recall3 reports
- NA 7210551Smith & Nephew, Inc. · Accessories, operating-room, table (kit)41 reports
- MAYFIELD® A1018Integra Lifesciences Corporation · Operating Room Accessories Table Tray36 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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