FDA Adverse Event
Malfunction
Summary report: N
SPHEREXII MAS DEFORMIT SYSTEM
MDR report key: 3371337
·
Received August 20, 2013
Report
- Report Number
- 2031966-2013-00042
- Event Type
- Malfunction
- Date Received
- August 20, 2013
- Date of Event
- July 6, 2013
- Report Date
- August 20, 2013
- Manufacturer
- NUVASIVE, INC.
- Product Code
- NKB
- PMA / PMN Number
- K102514
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS MDR WAS INCORRECTLY FILED AS 2031966-2013-00043. RESUBMITTED WITH 2031966-2013-00042.
Description of Event or Problem · 1
THE REPORTED INDICATES THAT IMMEDIATELY FOLLOWING INITIAL SURGERY ON (B)(6) 2013 FOR SCOLIOSIS CORRECTION OF L1-L5 WITH SUPPLEMENTAL BILATERAL FIXATION, THE SURGEON COULD NOT GET THE CORRECTION HE DESIRED. THE SURGEON HAD DIFFICULTIES IN INSERTING AND FINAL TIGHTENING OF THE LOCK SCREWS THROUGHOUT THE CONSTRUCT. SURGERY WAS COMPLETED AND THERE WAS NO INJURY TO THE PATIENT. SINCE THE SURGEON WAS UNABLE TO ACHIEVE THE CORONAL CORRECTION AND DESIRED CLINICAL OUTCOME, THE PATIENT WAS BROUGHT BACK IN FOR REVISION SURGERY (B)(6) 2013. SURGERY WAS COMPLETED AND PATIENT IS REPORTEDLY DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 402586 | SPHEREXII MAS DEFORMIT SYSTEM | SPINAL PEDICLE SCREW SYSTEM | NKB | NUVASIVE, INC. | 88000000 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |