FDA Adverse Event
Malfunction
Summary report: N
PEDICLE BLOCKER, STD., PREFERENCE II
MDR report key: 1635641
·
Received March 10, 2010
Report
- Report Number
- 3004744230-2010-00001
- Event Type
- Malfunction
- Date Received
- March 10, 2010
- Date of Event
- February 10, 2010
- Report Date
- March 3, 2010
- Manufacturer
- US SPINE, INC.
- Product Code
- MNI
- PMA / PMN Number
- K081883
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PATIENT RECEIVED SPINAL CONSTRUCT TO CORRECT SCOLIOSIS ON (B)(6) 2010. SUBSEQUENT TO THE SURGERY, THE PATIENT EXPERIENCED LOSS OF HEIGHT, REQUIRING THE SURGEON TO PERFORM A REVISION PROCEDURE. DURING THE REVISION PROCEDURE, THREE SET SCREWS AT THE BOTTOM OF THE CONSTRUCT WERE FOUND TO BE LOOSE. ONE OF THE THREE SET SCREWS WAS FOUND TO BE DISENGAGED FROM THE THREADS OF THE PEDICLE SCREW HEADBODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PEDICLE BLOCKER, STD., PREFERENCE II | MNI | US SPINE, INC. | 20-2500-001 | 103208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Required Intervention |