MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-30 for PYRAMESH IMPLANT SYSTEM UNK manufactured by Medtronic Sofamor Danek.
[32353762]
Literature citation : izumi t. , yamazaki a. , mizouchi t. , tashi h. , sano a. "local alignment by pyramesh-lt cage used for single intervertebral plif. " mean age: 62. 4 years. Gender: 154 male and 100 female. (b)(4). Neither the device nor applicable imaging films were returned to manufacturer therefore cause of event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[32353763]
It was reported in an abstract that total of 254 patients underwent single level posterior lumbar interbody fusion (plif) using cage in the period between 2004 - 2008. As post-op complications, 7 nonunions were observed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2015-03187 |
| MDR Report Key | 5255891 |
| Date Received | 2015-11-30 |
| Date of Report | 2015-10-27 |
| Date Mfgr Received | 2015-10-27 |
| Date Added to Maude | 2015-11-30 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | GREG ANGLIN |
| 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 | 0 |
| Brand Name | PYRAMESH IMPLANT SYSTEM |
| Generic Name | MESH, METAL |
| Product Code | EZX |
| Date Received | 2015-11-30 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Address | 1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-30 |