FDA Adverse Event
Injury
Summary report: N
LANX SPINAL FIXATION SYSTEM
MDR report key: 1581154
·
Received January 15, 2010
Report
- Report Number
- 3004485144-2010-00001
- Event Type
- Injury
- Date Received
- January 15, 2010
- Date of Event
- December 16, 2009
- Report Date
- December 16, 2009
- Manufacturer
- LANX, INC.
- Product Code
- JDN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PT'S INITIAL BACK PAIN WAS RESOLVED FOLLOWING IMPLANTATION OF THE DEVICE IN 2009. THE DEVICE WAS USED ACCORDING TO LABELED INDICATIONS WITH SUCCESSFUL RESULTS. THE EXPLANTED DEVICE WAS NOT AVAILABLE FOR EVAL BECAUSE IT WAS DISCARDED FOLLOWING THE SURGERY. HOWEVER, THERE IS NO INFO TO SUGGEST THAT THE DEVICE MALFUNCTIONED OR OTHERWISE FAILED TO PERFORM AS INTENDED. BASED ON THE INFO RECEIVED, THE ROOT CAUSE OF THE FRACTURE CANNOT BE DETERMINED.
Description of Event or Problem · 1
A REVISION SURGERY WAS PERFORMED APPROXIMATELY SIX MONTHS POST-OP TO REMOVE A SPINAL IMPLANT BECAUSE OF A RECURRENCE OF PAIN AND A FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LANX SPINAL FIXATION SYSTEM | SPINAL FIXATION SYSTEM | JDN | LANX, INC. | 6201-0014 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention |