FDA Adverse Event
Injury
Summary report: N
ARTHROSCOPE
MDR report key: 4151382
·
Received October 8, 2014
Report
- Report Number
- 2953769-2014-00128
- Event Type
- Injury
- Date Received
- October 8, 2014
- Date of Event
- September 16, 2014
- Report Date
- September 17, 2014
- Manufacturer
- MDT KYPHON NEUCHATEL MFG
- Product Code
- HRX
- PMA / PMN Number
- K041454
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(6). (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 UNDERWENT AN UNKNOWN KYPHOPLASTY PROCEDURE AT T6. DURING SURGERY, THE BALLOON RUPTURED THUS CAUSING A CANAL CEMENT LEAK. "THE DOCTORS NEEDED TO WAKE UP THE PATIENT FROM THE ANESTESIA IN ORDER TO CHECK THAT THE PATIENT COULD MOVE HIS LEGS. THERE WAS A DELAY IN OVERALL PROCEDURE TIME DUE TO THIS EVENT." NO FURTHER DETAILS ARE KNOWN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632910 | ARTHROSCOPE | ARTHROSCOPE | HRX | MDT KYPHON NEUCHATEL MFG | 0006887694 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00070 YR | Other |