NA 7210575Recalls & reported problems
Smith & Nephew, Inc. · WESTERN ELBOW POSITIONER · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010513915), received between Jun 14, 2019 and Nov 19, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
- Unstable1
Patient problems
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 19, 2020Unstable; Unstable
IT WAS REPORTED THAT THE POSITIONER ELBOW WESTERN WAS NOT HOLDING POSITION UNLESS IT IS TIGHTENED INTO PLACE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 10865739 ↗MalfunctionJun 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING SURGERY THE CLAMP SEIZED ON THREAD OF THE SCREW ARMREST WAS UNSTABLE. THERE WAS NO BACKUP DEVICE AVAILABLE. NO DELAY OR PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8701568 ↗
Other Accessories, operating-room, table (kit) devices
- MAYFIELD® A2101Integra Lifesciences Corporation · Operating Room Accessories Table Tray101 reports
- 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 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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