FDA Adverse Event
Injury
Summary report: N
KYPHX? HV-R? BONE CEMENT
MDR report key: 1904803
·
Received November 22, 2010
Report
- Report Number
- 2953769-2010-00580
- Event Type
- Injury
- Date Received
- November 22, 2010
- Date of Event
- October 20, 2010
- Report Date
- October 20, 2010
- Manufacturer
- MEDTRONIC SPINE LLC.
- Product Code
- NDN
- PMA / PMN Number
- ASKU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD - DEVICE NOT RETURNED, FOLLOW UP WOTH COMPANY REPRESENTATIVE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A KYPHOPLASTY PROCEDURE. DURING THE PROCEDURE A PIECE OF HARD CEMENT APPROXIMATELY 6 CM IN LENGTH REMAINED IN THE VERTEBRAL BODY. THE SURGEON MADE AN INCISION TO REMOVE THE CEMENT THREAD. THERE WERE NO PATIENT COMPLICATIONS. NO ADDITIONAL INFORMATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KYPHX? HV-R? BONE CEMENT | BONE CEMENT | NDN | MEDTRONIC SPINE LLC. | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | Other| R |