FDA Adverse Event
Injury
Summary report: N
INION S-1 SPINAL GRAFT CONTAINMENT PLATE
MDR report key: 2259108
·
Received September 15, 2011
Report
- Report Number
- 9710629-2011-00010
- Event Type
- Injury
- Date Received
- September 15, 2011
- Date of Event
- July 27, 2011
- Report Date
- September 13, 2011
- Manufacturer
- INION OY
- Product Code
- OJB
- PMA / PMN Number
- K071810
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
LOCAL FLUID ACCUMULATION: ANTICIPATED ADVERSE EVENT.
Description of Event or Problem · 1
AFTER A C5/6 ACDF SURGERY, DEBRIDEMENT AND ANTIBIOTICS 2 WEEKS POST OPERATIVE. REVISION SURGERY OF SOFT TISSUE ABSCESS AND IMPLANT REMOVAL 3 MONTHS POST OP. OBSERVATIONS: SCAR TISSUE IN NECK, NO INFECTION. PLATE INTACT. COLLAPSE OF C5 ONTO CAGE SEEN IN (B)(6) 2011 FILM (BEFORE THE REVISION). PATIENT CONDITION IS REPORTED GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INION S-1 SPINAL GRAFT CONTAINMENT PLATE | GRAFT CONTAINMENT PLATE | OJB | INION OY | SPN-5011 | 0811010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention | INION S-1 SCREWS FOR PPLATE FIXATION |