MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-01-30 for SATELLITE SPINAL SYSTEM 9000211 manufactured by Sofamor Danek Deggendorf Gmbh.
[17239749]
Device was returned to the manufacturer for evaluation. Evaluation is in process.
Patient Sequence No: 1, Text Type: N, H10
[17246898]
It was reported that the patient underwent a spinal procedure using interbody device at l4-l5 in 2007. The patient had pain post op. It was also found that the device subsided into the endplates. The revision surgery was performed approximately five months post op to remove the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2008-00039 |
| MDR Report Key | 990482 |
| Report Source | 07 |
| Date Received | 2008-01-30 |
| Date of Report | 2008-01-23 |
| Date of Event | 2008-01-17 |
| Date Mfgr Received | 2008-01-23 |
| Date Added to Maude | 2008-02-07 |
| 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 | CHAD ASHTON |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | SOFAMOR DANEK DEGGENFORF GMBH |
| Manufacturer Street | WERSTRASSE 17 |
| Manufacturer City | DEGGENDORF 94469 DE |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SATELLITE SPINAL SYSTEM |
| Generic Name | SPHERE |
| Product Code | NVR |
| Date Received | 2008-01-30 |
| Returned To Mfg | 2008-01-23 |
| Model Number | NA |
| Catalog Number | 9000211 |
| Lot Number | MY49 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 960190 |
| Manufacturer | SOFAMOR DANEK DEGGENDORF GMBH |
| Manufacturer Address | WERTSTRASSE 17 DEGGENDORF DE 94469 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-01-30 |