MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-24 for PYRAMESH IMPLANT SYSTEM UNK manufactured by Medtronic Sofamor Danek.
[109227206]
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[109227207]
Type of procedure or technique used: tes(posterior fusion performed at 2a2b) pre-operative diagnosis for this procedure : metastasis level: l1 it was reported that on (b)(6) 2018, post-op, the cage which was placed at l1 was sinking on the superior end plate. Patient had prolonged hospitalization due to the planned reoperation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2018-00740 |
| MDR Report Key | 7543446 |
| Date Received | 2018-05-24 |
| Date of Report | 2018-05-24 |
| Date of Event | 2018-04-26 |
| Date Mfgr Received | 2018-04-26 |
| Date Added to Maude | 2018-05-24 |
| 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 | STACIE ZIEMBA |
| 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 | 2018-05-24 |
| 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 | 2018-05-24 |