FDA Adverse Event
Other
Summary report: N
SPINELINK ANTERIOR CERVICAL SYSTEM
MDR report key: 288188
·
Received July 31, 2000
Report
- Report Number
- 2242816-2000-00015
- Event Type
- Other
- Date Received
- July 31, 2000
- Report Date
- July 31, 2000
- Manufacturer
- EBI, L.P.
- Product Code
- KWQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A COMPLAINT OF A PT WITH PROBLEMS SWALLOWING WAS REC'D. THE PT HAD UNDERGONE CERVICAL SPINAL FIXATION WITH THE SPINELINK ANTERIOR CERVICAL SYSTEM ONE YEAR AGO. A BARIUM SWALLOW TEST SHOWED NO BLOCKAGE BUT IT WAS NOTED ONE OF THE LOCK NUTS HAD DISLODGED. TO DATE THE PT HAS REFUSED SECOND SURGERY TO REMOVE THE COMPONENT. ALTHOUGH PRESENTLY THERE IS NO DEFINITIVE CONNECTION BETWEEN SPINELINK AND THE PT'S SWALLOWING SYMPTOMS, AN MDR IS BEING FILED FOR INFORMATIONAL PURPOSES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPINELINK ANTERIOR CERVICAL SYSTEM | INTERNAL FIXATION | KWQ | EBI, L.P. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |