Safedge 2108125000Recalls & reported problems
Stryker Corporation · Safedge 2108 Series Sagittal Blade Sternum Revision (40.3 x 0.64 x 48.4mm) · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540042088), received between Mar 25, 2024 and Mar 25, 2024 — classified as 1 death.
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. 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
- Insufficient Device Problem Information1
Patient problems
- Myocardial Infarction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMar 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING "OPENING OF THE STERNUM, INTRAOPERATIVELY, IT WAS REPORTED THAT THE SAW HAD FAILED, WHICH CAUSED MYOCARDIAL INJURY". FURTHER DETAILS PROVIDED STATED THAT THIS WAS AN ELECTIVE PROCEDURE FOR ATRIOVENTRICULAR SEPTUM CORRECTION. THE BLADE BEING USED WAS NOT REPORTED TO HAVE MALFUNCTIONED. IT WAS FURTHER REPORTED THAT DURING THE INCISION IN THE STERNUM, THE SAW WENT BEYOND THE BONE LIMITS AND REACHED STRUCTURES OF THE MYOCARDIAL MUSCLES. THE PATIENT DIED FOLLOWING THIS PROCEDURE.
Patient problems: Myocardial Infarction
MAUDE report 18967201 ↗
Other BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL devices
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- Formula 0375544000Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL98 reports
- NA 0277096325Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL95 reports
- NA 310.25Synthes GmbH · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL91 reports
- Arthrex® AR-8400TDArthrex, Inc. · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL86 reports
- NA 0277096275Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL72 reports
- Arthrex® AR-7300DSArthrex, Inc. · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL70 reports
- NA 0277096277Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL69 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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