FDA Adverse Event
Malfunction
Summary report: N
KYPHX HV-R BONE CEMENT
MDR report key: 1619648
·
Received February 26, 2010
Report
- Report Number
- 2953769-2010-00100
- Event Type
- Malfunction
- Date Received
- February 26, 2010
- Date of Event
- October 27, 2009
- Report Date
- October 27, 2009
- Manufacturer
- MEDTRONIC SPINE, LLC
- Product Code
- NDN
- PMA / PMN Number
- K033801
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
REPORT SOURCE: ABSTRACT (184) TITLED; "COMPARISON OF PERCUTANEOUS VERTEBROPLASTY AND KYPHOPLASTY IN TREATMENT OF PAINFUL VERTEBRAL COMPRESSION FRACTURES" " BY R. NI, L. CHEN, H. YANG, B. XU, T. TANG. METHOD: DEVICE NOT RETURNED, INTERNAL REVIEW OF LITERATURE, FOLLOW-UP WITH AUTHOR.
Description of Event or Problem · 1
IN AN ABSTRACT (184) TITLED "COMPARISON OF PERCUTANEOUS VERTEBROPLASTY AND KYPHOPLASTY IN TREATMENT OF PAINFUL VERTEBRAL COMPRESSION FRACTURES", THE FOLLOWING EVENTS WERE REPORTED: FIVE CASES OF PMMA CEMENT LEAKAGE OCCURRED IN PERCUTANEOUS KYPHOPLASTY PROCEDURE PATIENTS, BUT RESULTED IN NO CLINICAL CONSEQUENCES. THERE WERE NO OTHER MAJOR COMPLICATIONS ENCOUNTERED. NOTE: AT THE TIME OF THESE EVENTS, KYPHOPLASTY PRODUCTS WERE NOT DISTRIBUTED IN (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KYPHX HV-R BONE CEMENT | HIGH VISCOSITY, RADIOPAQUE BONE CEMENT | NDN | MEDTRONIC SPINE, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |