FDA Adverse Event
Malfunction
Summary report: N
LANX ANTERIOR CERVICAL PLATE SYSTEM
MDR report key: 2021394
·
Received February 8, 2011
Report
- Report Number
- 3004485144-2011-00020
- Event Type
- Malfunction
- Date Received
- February 8, 2011
- Date of Event
- January 14, 2011
- Report Date
- January 17, 2011
- Manufacturer
- LANX, INC.
- Product Code
- KWQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO DEVICES WERE RETURNED FOR EVAL. FEEDBACK FROM THE INITIAL REPORTER INDICATED, THE SURGEON ELECTED TO ANGLE THE SCREWS IN A MANNER WHICH PREVENTED PLACEMENT OF THE CAPS. THE SURGEON INDICATED TO THE INITIAL REPORTER THAT THE SCREWS WERE PLACED ALONG THE CORTICAL EDGE OF THE BONE AND CONSIDERED THE CONSTRUCT STABLE.
Description of Event or Problem · 1
FOUR LOCKING CAPS WERE NOT INSTALLED DURING INSTALLATION OF THREE-LEVEL ANTERIOR PLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LANX ANTERIOR CERVICAL PLATE SYSTEM | ANTERIOR CERVICAL PLATE SYSTEM | KWQ | LANX, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |