FDA Adverse Event
Malfunction
Summary report: N
OPTIMESH 1500S
MDR report key: 2039206
·
Received February 22, 2011
Report
- Report Number
- 2135156-2011-00001
- Event Type
- Malfunction
- Date Received
- February 22, 2011
- Date of Event
- January 19, 2011
- Report Date
- February 22, 2011
- Manufacturer
- SPINEOLOGY, INC.
- Product Code
- EZX
- PMA / PMN Number
- K014200
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT REC'D A L3-L4 FUSION APPROX 2 YEARS PRIOR TO A RECENT MOTOR VEHICLE ACCIDENT. THE PT DEVELOPED LOW BACK PAIN AFTER THE ACCIDENT AND A CT SCAN SHOWED A LARGE MASS IN THE SPINAL CANAL. THE PT WAS TAKEN TO SURGERY TO REMOVE THE MASS WHICH TURNED OUT TO BE UNCONSTRAINED BONE GRAFT AND THE OPTIMESH DEVICE. THE PREVIOUSLY INSERTED PEDICLE SCREW CONSTRUCT WAS ALSO REVISED AT THAT TIME. THE PT HAD NEW ALLOGRAFT AND A NEW PEDICLE SCREW CONSTRUCT IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPTIMESH 1500S | SURGICAL MESH | EZX | SPINEOLOGY, INC. | 1500S | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | PEDICLE SCREWS IMPLANTED WITH THE OPTIMESH| DEVICE APPROXIMATELY 2 YEARS PRIOR. |