MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-11-09 for KYPHON EXPRESS INFLATABLE BONE TAMP KE152 manufactured by Medtronic Mexico S. De R.l De C.v..
[127366436]
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
[127366437]
Patient medical history: osteoporosis pre-operative diagnosis for this procedure: primary osteoporosis with compression fractures at t12, l1, and l2 vertebral bodies levels implanted: t12, l1, l2 it was reported that on (b)(6) 2018, intra-op, ibt (inflatable bone tamp) ruptured at 402 psi and 2cc after coming in contact with a bone shard. The deflated ibt was unable to be pulled back through the cannula. The doctor had to pull out entire trocar and re-access the bone. There was a delay of 5 minutes in overall procedure time; however, the procedure was completed successfully with a new product. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2018-03140 |
| MDR Report Key | 8057802 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-09 |
| Date of Report | 2018-11-09 |
| Date of Event | 2018-10-12 |
| Date Mfgr Received | 2018-10-12 |
| Date Added to Maude | 2018-11-09 |
| 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 MEXICO S. DE R.L DE C.V. |
| Manufacturer Street | AVENIDA PASEO CUCAPAH # 10510 PARQUE INDUSTRIAL EI LAGO |
| Manufacturer City | TIJUANA,BC 22570 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22570 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYPHON EXPRESS INFLATABLE BONE TAMP |
| Generic Name | TAMP |
| Product Code | HXG |
| Date Received | 2018-11-09 |
| Model Number | NA |
| Catalog Number | KE152 |
| 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 MEXICO S. DE R.L DE C.V. |
| Manufacturer Address | AVENIDA PASEO CUCAPAH # 10510 PARQUE INDUSTRIAL EI LAGO TIJUANA,BC 22570 MX 22570 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-09 |