FDA Adverse Event
Injury
Summary report: N
SPIDER CERVICAL PLATING SYSTEM 4X14MM SCREW
MDR report key: 2100428
·
Received May 16, 2011
Report
- Report Number
- 3005031160-2011-00004
- Event Type
- Injury
- Date Received
- May 16, 2011
- Report Date
- April 25, 2011
- Manufacturer
- X-SPINE SYSTEMS, INC.
- Product Code
- KWQ
- PMA / PMN Number
- K052292
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: ANTERIOR CERVICAL DISCECTOMY AND FUSION C4-C6. ACCORDING TO THE REPORTER: THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2010. ONE SCREW BROKE 6 MONTHS POST-OPERATIVELY. SCREW HAS NOT BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPIDER CERVICAL PLATING SYSTEM 4X14MM SCREW | CERVICAL PLATING SYSTEM | KWQ | X-SPINE SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |