Medtronic Reusable Instrument 6550102Recalls & reported problems
Medtronic Sofamor Danek, Inc. · BONE FILLER DEVICE 6550102 BOX OF 2 BFD · Class 1
All models of Medtronic Reusable Instrument (3)
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 20763000211015), received between Jun 24, 2022 and Jun 24, 2022 — classified as 1 death.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
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.
DeathJun 24, 2022Leak/Splash; Leak/Splash
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH DISCITIS INFECTION AT THE L3/4 FOR TWO LEVEL OLIF. IT WAS REPORTED THAT CEMENT PASSED THROUGH DEVICE HOWEVER, MULTIPLE TIMES THE CEMENT DID NOT TRAVEL DOWN SHANK OF SCREW TO VERTEBRAL BODY FOR SURGEON DESIRED PLACEMENT. CEMENT CAME BACK UP THROUGH THE TULIP HEAD OF PEDICLE SCREW AND DORSAL SOFT TISSUE OF PATIENT. TWO OF THESE TIPS DISCONNECTED FROM THE CEMENT DELIVERY GUIDE (6550041) WITHIN THE TULIP HEAD AND WERE ENCASED IN CEMENT. FNS TIP 6550202 DID NOT CONTAIN CEMENT UPON IMPLANTATION AND DISCONNECTED FROM CEMENT DELIVERY GUIDE (6550041) THAT ARE CONTAINED WI THIN THIS SET AND REQUIRE INSPECTION. PATIENT DEATH OCCURRED DURING PROCEDURE. CAUSE OF DEATH STILL UNDETERMINED. PATIENT WAS PRONOUNCED DECEASED IN THE OPERATING ROOM INTRAOPERATIVELY. IT WAS ALSO REPORTED THAT THE CEMENT DELIVERY DEVICE LEAKED CEMENT INTO TULIP HEAD. THE LEAKED CEMENT INTO THE TULIP APPEARED TO BE NOT DANGEROUS TO THE PATIENT. PATIENT DEATH WAS REPORTED, HOWEVER, NO INFORMATION REGARDING CAUSE AND CIRCUMSTANCES OF DEATH WAS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING T
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14797696 ↗
Other DISPENSER, CEMENT devices
- SMARTSET 3102-080Depuy (Ireland) · DISPENSER, CEMENT75 reports
- Medtronic Reusable Instrument 6550202Medtronic Sofamor Danek, Inc. · DISPENSER, CEMENT2 deaths59 reports
- KYPHON® Express™ Directional Bone Filler Device F06BMedtronic Sofamor Danek, Inc. · DISPENSER, CEMENT1 recall1 report
- EXPEDIUM 279726500Medos International Sàrl · DISPENSER, CEMENT44 reports
- Revolution 0606600000Stryker Corporation · DISPENSER, CEMENT33 reports
- n/a 6550041Medtronic Sofamor Danek, Inc. · DISPENSER, CEMENT16 reports
- NA 0606100000Stryker Corporation · DISPENSER, CEMENT15 reports
- NA 0206600000Stryker Corporation · DISPENSER, CEMENT14 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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