KYPHON® Express™ Directional Bone Filler Device F06BRecalls & reported problems
Medtronic Sofamor Danek, Inc. · BONE FILLER DEVICE F06B DIRECT SIZE 2 · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169097254), received between Jul 3, 2020 and Jul 3, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Expiration Date Error” (1 report).
1 FDA recall record name this device's 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, 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.
Recalls naming this device
- Dec 6, 2017Class IITerminated
Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument.
Z-0352-2018 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Expiration Date Error1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2020Expiration Date Error; Expiration Date Error
INFORMATION WAS RECEIVED FROM A FIELD REPRESENTATIVE REGARDING A BONE FILLER DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT INTRA-OP, THE BONE FILLER USED WAS EXPIRED. THERE IS NO KYPHON CONSIGNED AT THE HOSPITAL, SO ALL THE PRODUCTS WERE SENT BY MEDTRONIC TO THE HOSPITAL ONE DAY BEFORE THIS SURGERY. NURSE TOOK THE MATERIAL TO THE OPERATING ROOM. THE STICKER WAS GLUED IN THE EXPENSE SHEET. AFTER SURGERY THE PURCHASE DEPARTMENT NOTICED THAT THE PRODUCT USED WAS EXPIRED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE ORIGINAL PRODUCT AND TWO LEVELS WERE IMPLANTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10228804 ↗
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- Medtronic Reusable Instrument 6550202Medtronic Sofamor Danek, Inc. · DISPENSER, CEMENT2 deaths59 reports
- 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
- N/A 6550044Medtronic Sofamor Danek, Inc. · DISPENSER, CEMENT11 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 · each recall links to the FDA recall notice
- 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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