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 2011-05-05 for SATELLITE SPINAL SYSTEM 6000213 manufactured by Medtronic Sofamor Danek Deggendorf Gmbh.
[1977279]
It was reported that during an unspecified spinal procedure, the implant broke and then detached from the inserter during insertion. The implant was broken into pieces with first hammering during implantation. Another implant was used and no patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[9187415]
(b)(4). This part is not approved for use in the united states; however a like device, procode nvr was cleared in the united states. This part is not approved for use in the united states; however a like device, 510k # k060415 was cleared in the united states. A chip of peek has been broken off the sphere at the level of the attachment to the implant inserter. The breakage occurred at the end of the threaded hole portion and at the bottom of the lateral handling hole. The chip presents cylindrical marks around the threaded hole corresponding to the contact with the implant inserter. The chip presents also a crack starting from the threaded hole through the handling hole and the outside surface of the sphere. The sphere presents a shaving at the level of the breakage on the outer sphere surface. This shaving is opposite to the handling hole. The last thread of the threaded hole has been shorn off and perpendicular to the shaving. The part returned was found 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 (shaving and shear thread) suggest that the breakage is consistent with an over-loading 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2011-00492 |
| MDR Report Key | 2079198 |
| Report Source | 01,05,07 |
| Date Received | 2011-05-05 |
| Date of Report | 2011-04-05 |
| Date of Event | 2011-04-05 |
| Date Mfgr Received | 2011-04-05 |
| Device Manufacturer Date | 2007-06-27 |
| Date Added to Maude | 2011-05-26 |
| 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 | CHAD ASHTON |
| 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 | 2011-05-05 |
| Returned To Mfg | 2011-04-19 |
| Catalog Number | 6000213 |
| Lot Number | NB34 |
| Device Expiration Date | 2012-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2011-05-05 |