KyphPak® First Fracture Tray KPX103PB-CDSRecalls & reported problems
Medtronic Sofamor Danek, Inc. · KIT KPX103PB-CDS 10/3 FF 1-STEP WITH CDS · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169671720), received between Nov 30, 2021 and Nov 30, 2021 — classified as 1 injury.
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
- Dyspnea1
- Extravasation1
- Pulmonary Embolism1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 30, 2021Leak/Splash; Leak/Splash
INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS- COMPRESSION FRACTURE L1, L2 INVOLVED IN KYPHOPLASTY PROCEDURE. LEVELS IMPLANTED- L1, L2. IT WAS REPORTED THAT INTRA-OPERATIVELY, KYPHOPLASTY PROCEDURE WAS PERFORMED ON (B)(6) 2021 AT LEVEL L1, L2. WHILE INJECTING CEMENT A PPEARED TO BE EXTRAVASATED, THEY STOPPED INJECTING AT THAT POINT AND COMPLETED PROCEDURE. CEMENT WAS STORED AT PROPER TEMPERATURE(S) BEFORE AND DURING THE PROCEDURE. CEMENT WAS MIXED APPROXIMATELY FOR 1MINUTE 30 SECONDS. CEMENT WAS DOUGHY AND HOMOGENOUS PRIOR TO DELIVERY INTO THE PATIENT. ON (B)(6) 2021, PATIENT WENT TO EMERGENCY DEPARTMENT EITHER OVER WEEKEND OR EARLIER OF THE WEEK AND IMAGING DETECTED PULMONARY EMBOLISM. PATIENT HAD A COUGHING EVENT DURING CASE PRIOR TO ANY CEMENT BEING INJECTED. MAC ANESTHESIA WAS USED FOR CASE. ON 2021-NOV-19, RECEIVED ADDITIONAL INFORMATION THAT CEMENT APPEARED TO EXTRAVASATED AWAY FROM TREATED LEVEL (APPEARED LATERAL TO VERTEBRAL BODY AND MOVED AWAY). DOCTOR BELIEVED CEMENT CAUSED PULMONARY EMBOLISM. NO PLAN FOR REVISION SURGERY. PATIENT WAS NOT HOSPITALIZED PROLONG. PATIENT STATUS WAS OKAY AND MILDLY SHORT
Patient problems: Dyspnea; Extravasation; Pulmonary Embolism
MAUDE report 12890019 ↗
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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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