Tritium Sternal Cable Plate SystemRecalls & reported problems across all models
Pioneer Surgical Technology, Inc. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of Tritium Sternal Cable Plate System by Pioneer Surgical Technology, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Aug 23, 2017 and Aug 23, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Tritium Sternal Cable Plate System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 11, 2014Class IITerminated
Lack of Sterility Assurance
Z-2076-2014 · Root cause: Employee error · Recall details · FDA record ↗
Most reported Tritium Sternal Cable Plate System problems
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Tritium Sternal Cable Plate System models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Tritium® Sternal Cable Plate System 86-27-12-S12CERCLAGE, FIXATION1 recall0 reports
- Tritium® Sternal Cable Plate System 86-500Plate, fixation, bone1 report
Recent Tritium Sternal Cable Plate System adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 23, 2017Break; Break
DURING A STERNUM CLOSURE THE SURGEON BROKE THREE STERNAL PLATES WHILE ATTEMPTING TO CRIMP THE CABLE TO THE PLATES. ACCORDING TO THE REPORT THERE WAS NO ADVERSE EVENT CAUSED BY THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6812833 ↗
Other Pioneer Surgical Technology, Inc. products
All Pioneer Surgical Technology, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page