FDA Adverse Event
Other
Summary report: N
OPTIMESH
MDR report key: 1239143
·
Received November 17, 2008
Report
- Report Number
- 2135156-2008-00002
- Event Type
- Other
- Date Received
- November 17, 2008
- Date of Event
- October 21, 2008
- Report Date
- October 17, 2008
- Manufacturer
- SPINEOLOGY, INC.
- Product Code
- EZX
- PMA / PMN Number
- K014200
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF CT SCAN PRIOR TO REVISION DID NOT INDICATE OBVIOUS COMPROMISE OF DEVICE, BUT BONE WAS NOTED IN THE FORAMEN. DR. IS CONCERNED THAT NERVE ROOT MAY HAVE BEEN STRETCHED/IRRITATED BY RETRACTION DURING THE SECOND SURGERY.
Description of Event or Problem · 1
PT REPORTED LEG AND GROIN PAIN FOLLOWING INTERBODY FUSION SURGERY. SURGEON WAS CONCERNED THAT CONTAINMENT MESH MAY HAVE BEEN COMPROMISED. DEVICE AND BONE GRAFT WERE EXPLANTED ONE WEEK AFTER ORIGINAL SURGERY AND A NEW DEVICE WAS PLACED FROM THE CONTRALATERAL SIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPTIMESH | GRAFT CONTAINMENT MESH | EZX | SPINEOLOGY, INC. | 1500E | S08005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Hospitalization| O |