MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2011-12-22 for SATELLITE SPINAL SYSTEM 6000213 manufactured by Medtronic Sofamor Danek Deggendorf Gmbh.
[20277056]
A review of the device history records for this device did not reveal any non-conformances to specification or deviations in procedure which might contribute to the reported event.
Patient Sequence No: 1, Text Type: N, H10
[21359942]
(b)(4). Analysis of the returned device showed it to be broken at the level of the attachment with the implant inserter. No pre-existing defect was found at the level of the breakage. The observations of the chip and the broken section of the sphere suggest that the breakage is consistent with an overloading of the part and the origin of the over-loading can be attributed to the application of a lateral load on the implant inserter during the implantation of the sphere. This lateral load could be linked to a misalignment of the inserter with intervertebral disc space during implantation. A review of the device history records for this device did not reveal any non-conformances to specification or deviations in procedure which might contribute to the reported event.
Patient Sequence No: 1, Text Type: N, H10
[21366277]
It was reported that a patient underwent an unknown spinal procedure. During the procedure, the implant broke upon insertion. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2011-01633 |
| MDR Report Key | 2386144 |
| Report Source | 01,05,07 |
| Date Received | 2011-12-22 |
| Date of Report | 2011-12-10 |
| Date of Event | 2011-12-08 |
| Date Mfgr Received | 2011-12-10 |
| Device Manufacturer Date | 2006-12-05 |
| Date Added to Maude | 2012-02-17 |
| 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 | 3 |
| Manufacturer Contact | HUZEFA MAMOOLA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SATELLITE SPINAL SYSTEM |
| Product Code | NVR |
| Date Received | 2011-12-22 |
| Returned To Mfg | 2011-12-15 |
| Catalog Number | 6000213 |
| Lot Number | MK86 |
| Device Expiration Date | 2012-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH |
| Manufacturer Address | WERFTSTRASSE 17 DEGGENDORF,DE 94469 94469 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-22 |