FDA Adverse Event
Malfunction
Summary report: N
ARTHROSCOPE
MDR report key: 4130120
·
Received September 30, 2014
Report
- Report Number
- 2953769-2014-00122
- Event Type
- Malfunction
- Date Received
- September 30, 2014
- Date of Event
- July 11, 2014
- Report Date
- September 3, 2014
- Manufacturer
- MDT KYPHON NEUCHATEL MFG
- Product Code
- HRX
- PMA / PMN Number
- K041454
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT WITH AN OSTEOPOROTIC COMPRESSION FRACTURE UNDERWENT A BKP AT T12. DURING THE PROCEDURE, A BALLOON RUPTURED INSIDE THE VERTEBRAL BODY. NO FRAGMENT OF THE BALLOON WAS LEFT IN THE PATIENT BODY. THE SURGICAL TIME WAS NOT EXTENDED DUE TO THE INCIDENT. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607817 | ARTHROSCOPE | HRX | MDT KYPHON NEUCHATEL MFG | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | BKP KIT |