MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-02-25 for SATELLITE NUCLEUS REPLACEMENT UNK manufactured by Sofamor Danek Deggendorf Gmbh.
[801143]
It was reported that the patient underwent a spinal procedure using the peek device at l4-l5. The device migrated post op. The revision surgery was performed to remove and replace the device.
Patient Sequence No: 1, Text Type: D, B5
[7936857]
Device was not returned to the manufacturer for evaluation. Unable to determine the cause of the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2008-00101 |
| MDR Report Key | 1002480 |
| Report Source | 07 |
| Date Received | 2008-02-25 |
| Date of Report | 2008-02-19 |
| Date of Event | 2008-02-14 |
| Date Mfgr Received | 2008-02-19 |
| Date Added to Maude | 2008-02-28 |
| 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 38133 |
| Manufacturer Country | US |
| Manufacturer Postal | 38133 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | SOFAMOR DANEK DEGGENDORF GMBH |
| Manufacturer Street | WERTSTRASSE 17 |
| Manufacturer City | DEGGENDORF 94469 |
| Manufacturer Postal Code | 94469 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SATELLITE NUCLEUS REPLACEMENT |
| Generic Name | SPHERE |
| Product Code | NVR |
| Date Received | 2008-02-25 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 971683 |
| Manufacturer | SOFAMOR DANEK DEGGENDORF GMBH |
| Manufacturer Address | WERTSTRASSE 17 DEGGENDORF 94469 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-02-25 |