MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-20 for KYPHON XPANDER? INFLATABLE BONE TAMP K09A manufactured by Medtronic Sofamor Danek Usa, Inc.
[117961625]
Product was not returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[117961626]
It was reported that the patient was pre-operatively diagnosed with primary osteoporosis and underwent balloon kyphoplasty (bkp) procedure at l1 level. During surgery, the balloon ruptured while inflating. The product came in contact with the patient. No fragment of the balloon remained in the patient. It was calculated that there was 3 ml of the contrast media remained in the patient. The patient was not allergic to contrast media. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2018-01154 |
| MDR Report Key | 7796422 |
| Date Received | 2018-08-20 |
| Date of Report | 2018-08-20 |
| Date of Event | 2018-07-23 |
| Date Mfgr Received | 2018-07-23 |
| Date Added to Maude | 2018-08-20 |
| 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 USA, INC |
| Manufacturer Street | 4340 SWINEA RD |
| Manufacturer City | MEMPHIS TN 38118 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38118 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KYPHON XPANDER? INFLATABLE BONE TAMP |
| Generic Name | TAMP |
| Product Code | HXG |
| Date Received | 2018-08-20 |
| Model Number | NA |
| Catalog Number | K09A |
| 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 | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-20 |