FDA Adverse Event
Malfunction
Summary report: N
ADJ. X-CONN. LARGE 55.5-81.0MM
MDR report key: 1880901
·
Received October 4, 2010
Report
- Report Number
- 1530901-2010-00113
- Event Type
- Malfunction
- Date Received
- October 4, 2010
- Date of Event
- August 31, 2010
- Report Date
- October 4, 2010
- Manufacturer
- THEKEN SPINE
- Product Code
- NKB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN EVALUATED. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
THE REPORTER STATED THAT DURING A SPINAL SURGERY PROCEDURE, THE CORAL ADJUSTABLE CROSSLINK FAILED AND THE PARTS SEPARATED. INTEGRA HAS REQUESTED ADDITIONAL CLINICAL INFO FROM THE REPORTER. THE CORAL SPINAL SYSTEM IS A FUSION IMPLANT SYSTEM USED FOR THE CORRECTION AND STABILIZATION OF THE LUMBAR OR LOWER REGION OF THE SPINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADJ. X-CONN. LARGE 55.5-81.0MM | CORAL | NKB | THEKEN SPINE | W2808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |