MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-01-15 for LANX SPINAL FIXATION SYSTEM 7703-1600 manufactured by Lanx, Llc.
[4144553]
Approximately six months post-op, x-rays showed one set screw had backed out of an offset connector. Currently, there are no revision plans.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004485144-2013-00039 |
| MDR Report Key | 3593240 |
| Report Source | 08 |
| Date Received | 2014-01-15 |
| Date of Report | 2013-12-17 |
| Date of Event | 2013-12-16 |
| Date Mfgr Received | 2013-12-17 |
| Date Added to Maude | 2014-03-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GARY TURNER |
| Manufacturer Street | 310 INTERLOCKEN PKWY SUITE 120 |
| Manufacturer City | BROOMFIELD CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal | 80021 |
| Manufacturer Phone | 3034437500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LANX SPINAL FIXATION SYSTEM |
| Generic Name | PEDICLE SCREW SPINAL SYSTEM |
| Product Code | MCV |
| Date Received | 2014-01-15 |
| Model Number | 7703-1600 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LANX, LLC |
| Manufacturer Address | BROOMFIELD CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-15 |