MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2009-02-26 for SATELLITE SPINAL SYSTEM MSD676 manufactured by Warsaw Orthopedic Inc..
[1031459]
It was reported by a non-medical professional that the patient underwent a lumbar stabilization procedure in 2006 where an interbody stabilization device was implanted. The patient underwent a surgical revision to remove the device in 2007 reportedly, due to problems resulting from the initial surgery and the device.
Patient Sequence No: 1, Text Type: D, B5
[2245313]
The revision surgery was done on (b)(6) 2007.
Patient Sequence No: 1, Text Type: D, B5
[8179525]
.
Patient Sequence No: 1, Text Type: N, H10
[9288636]
Imaging studies were provided for review. Pre-op lumbar views and mri axials appear normal. Post-op films show interbody device at l5-s1. 4 weeks post-op shows subsidence into l5. Final films show the level revised with interbody peek spacer, graft and unilateral pedicle screws on the right at l5-s1. Screws are noted to extend beyond the vertebral body anteriorly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2009-00200 |
| MDR Report Key | 1327862 |
| Report Source | 00 |
| Date Received | 2009-02-26 |
| Date of Report | 2009-02-05 |
| Date of Event | 2007-04-16 |
| Date Mfgr Received | 2011-08-15 |
| Date Added to Maude | 2009-03-05 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHAD ASHTON |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | WARSAW ORTHPEDIC INC. |
| Manufacturer Street | 2500 SILVEUS CROSSING |
| Manufacturer City | WARSAW IN 46852 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46852 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SATELLITE SPINAL SYSTEM |
| Generic Name | SPHERE |
| Product Code | NVR |
| Date Received | 2009-02-26 |
| Model Number | MSD676 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WARSAW ORTHOPEDIC INC. |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46852 US 46852 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-02-26 |