FDA Adverse Event
Injury
Summary report: N
ARRAY SPINAL SYSTEM
MDR report key: 1185423
·
Received October 6, 2008
Report
- Report Number
- 2242816-2008-00141
- Event Type
- Injury
- Date Received
- October 6, 2008
- Date of Event
- September 19, 2008
- Report Date
- September 24, 2008
- Manufacturer
- EBI, LLC
- Product Code
- MNI
- PMA / PMN Number
- K061978
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL DEVICES: PART NUMBER 5006400, LOT PN60B, DATE OF MANUFACTURE 08/01/2007. PART NUMBER 5006819, LOT 203490, DATE OF MANUFACTURE 12/01/2007. PART NUMBER 5006810, LOT 203420, DATE OF MANUFACTURE 12/01/2007. PART NUMBER 5006809, LOT 203400, DATE OF MANUFACTURE 12/01/2007. THE PACKAGE INSERT STATES, "BENDING, FRACTURE, LOOSENING OR MIGRATION OF THE IMPLANT", AS A POSSIBLE ADVERSE EFFECT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SET SCREWS BACKED OUT AT L2 AND L3 BILATERALLY. THE ORIGINAL SURGERY WAS A T4-L3 PSF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARRAY SPINAL SYSTEM | ORTHOSIS, SPINAL PEDICLE FIXATION | MNI | EBI, LLC | 297410 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Required Intervention |