A&E Medical / Thorecon™ Double Cable Plate Kit (inc. screws & cables, shrp ndl) 94-1300-04-SRecalls & reported problems
A & E Medical Corporation · Double Cable Plate Kit (inc. screws & cables, shrp ndl) · Class 2
Data updated Oct 18, 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 10841291105657), received between Sep 20, 2019 and Jan 5, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2026Fracture
IT WAS REPORTED THAT DURING IMPLANTATION, THE NEEDLE FRACTURED OFF FROM THE WIRE LEAD WITHOUT ANY FORCE BEING APPLIED, RENDERING THE PRODUCT UNUSABLE. THE NEEDLE WAS SUCCESSFULLY REMOVED FROM THE SURGICAL SITE. HOWEVER, THE PRODUCT WAS UNUSABLE AND THE PROCEDURE WAS COMPLETED BY REMOVING THE IMPLANT AND USING A NEW ONE. THERE WAS NO PATIENT INJURY OR HARM AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23957842 ↗MalfunctionSep 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
WHILE USING THE THORECON® PLATING SYSTEM A SURGEON TRIED TO TIGHTEN DOWN A SET SCREW IN ORDER TO SECURE THE CABLE. THE SCREW DID NOT TIGHTEN AS DESIGNED, BUT INSTEAD SPUN FREELY IN THE PLATE. THE SURGEON PROCEEDED TO USE A STERNUM WIRE OVER THE PLATE AS HE OR SHE BELIEVED IT WAS NECESSARY FOR EXTRA STABILITY. NO DEVICE WAS NOT RETURNED FOR INVESTIGATION. NO PATIENT HARM WAS INDICATED. THE EXACT DATE OF THE PROCEDURE IS UNKNOWN, HOWEVER, IT WAS INDICATED THAT IT OCCURRED IN THE FIRST WEEK OF AUGUST.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9098623 ↗
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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