MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-05-11 for UNK manufactured by Medtronic Sofamor Danek Usa, Inc..
[144819811]
Product was not returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the r eported event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[144819812]
It was reported that the patient underwent balloon kyphoplasty. Intra-op, the inner stylet of the inflatable bone tamp pierced the balloon about 1 cm when it was inserted in vertebral body. The physician pushed stylet back into balloon and re-used it. The procedure was not affected. There were no patient complications as a result of the alleged event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2019-00526 |
| MDR Report Key | 8602294 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-05-11 |
| Date of Report | 2019-05-11 |
| Date of Event | 2019-04-12 |
| Date Mfgr Received | 2019-04-12 |
| Date Added to Maude | 2019-05-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 USA, INC. |
| 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 |
| Generic Name | TAMP |
| Product Code | HXG |
| Date Received | 2019-05-11 |
| 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 USA, INC. |
| Manufacturer Address | 1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-11 |