A&E Medical / Thorecon™ Double Cable Plate Kit (inc. screws & cable) 94-1300-04Recalls & reported problems
A & E Medical Corporation · Double Cable Plate Kit (inc. screws & cable) · Class 2
Data updated Oct 18, 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 10841291105640), received between Jul 6, 2021 and Jul 6, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
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.
MalfunctionJul 6, 2021Break; Break
A DISTRIBUTOR ASSOCIATE REPORTED THAT THE THORECON SCREW BROKE WHEN PLACING INTO THE BONE DURING A STERNOTOMY PROCEDURE AT AURORA BAY CARE HOSPITAL IN GREEN BAY, WI. THE SURGEON STATED THAT THE SCREW FELT DIFFERENT. THE SURGEON WAS ABLE TO GET IT OUT OF THE PATIENT BY USING ANOTHER INSTRUMENT TO GET THE SCREW OUT. THE SCREW BROKE INTO TWO PIECES; ONE PIECE WAS IN THE PATIENT BUT WAS REMOVED. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12124910 ↗
Other Cable, Electrode devices
- N/A ECG Leadwire set, 5-lead, grouped, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall1 report
- N/A ECG TRUNK CABLE, 6-LEAD, AHA, 1.2 M/4 FTGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG Leadwire set, 5-lead V2-6, grabber, AHA, 74 cm/ 29 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, IEC, 3.6 M/12 FTGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG Leadwire set, 3-lead, snap, AHA, 74 cm/ 29 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG TRUNK CABLE, 3/5-LEAD, AHA, 6 M/20 FTGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG Leadwire set, 5-lead, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG Leadwire set, 5-lead, grouped, snap, AHA, 74 cm/ 29 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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