FDA Adverse Event
Injury
Summary report: N
KYPHON INFLATABLE BONE TAMP
MDR report key: 2162755
·
Received July 14, 2011
Report
- Report Number
- 2953769-2011-00084
- Event Type
- Injury
- Date Received
- July 14, 2011
- Report Date
- June 13, 2011
- Manufacturer
- MEDTRONIC SPINE LLC.
- Product Code
- HRX
- PMA / PMN Number
- K981251
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP WITH COMPANY REPRESENTATIVE.
Description of Event or Problem · 1
IT WAS REPORTED IN A CASE STUDY THAT A PATIENT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE. LATERAL X-RAYS SHOWED LATE COLLAPSE OF ENDPLATE DOWN TO CEMENT BOLUS WITH CONTINUED PAIN. CONSIDERABLE LOSS OF DISC HEIGHT THREE WEEKS AFTER KYPHOPLASTY. ENDPLATE SETTLING AND SUBSEQUENT VERTEBRA BODY COLLAPSE; DISC DEGENERATION ADJACENT TO ENDPLATE FRACTURE. NO FURTHER INFORMATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KYPHON INFLATABLE BONE TAMP | ARTHROSCOPE | HRX | MEDTRONIC SPINE LLC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |