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 2019-06-28 for KYPHON EXPRESS II INFLATABLE BONE TAMP KE152 manufactured by Medtronic Mexico.
[149557443]
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
[149557444]
It was reported that the patient underwent balloon kyphoplasty at l1 due to vertebral compression fracture. Intra-op, when balloon was inflated, contrast leaked from the top y-intersection of the inflatable bone tamp. The procedure was however completed with the same product. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[170785629]
Product analysis: visual and optical inspection did not reveal any damages to the balloon or the shaft of the ibt. Functional inspection with a sample syringe confirmed the ibt when under pressure was leaking out the shaft near the connector valve. It appears the shaft was separated from the valve at one point. Unable to determine root cause of shaft separation. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2019-02592 |
| MDR Report Key | 8745451 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-06-28 |
| Date of Report | 2019-10-07 |
| Date of Event | 2019-05-22 |
| Date Mfgr Received | 2019-10-03 |
| Date Added to Maude | 2019-06-28 |
| 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 |
| Manufacturer Street | AV. PASEO DEL CUCAPAH #10510 |
| 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 II INFLATABLE BONE TAMP |
| Generic Name | TAMP |
| Product Code | HXG |
| Date Received | 2019-06-28 |
| Returned To Mfg | 2019-07-17 |
| Model Number | NA |
| Catalog Number | KE152 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC MEXICO |
| Manufacturer Address | AV. PASEO DEL CUCAPAH #10510 TIJUANA,BC 22570 MX 22570 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-28 |