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 2020-03-28 for KYPHON V OSTEO INTRODUCER 13GA TROCAR/BEVEL VPT13D manufactured by Medtronic Mexico.
[189090395]
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
[189090396]
It was reported that intra-op, trocar got stuck in the vertebral body, possibly due to heavy malleting and denser than normal bone. Upon attempting to pull out trocar, the purple hub on superficial end ripped off from the trocar placed in the pedicle and vertebral body. At times, physician was pulling so hard on the needle that the patient was being lifted off of the table. Once the purple hub ripped off, the surgeon had to use vice grips and a mallet to remove the needle from patient to prevent an open spine surgery to remove. The doctor was sure that the bond between the hub and cannula became loose due to heavy malleting. The patient had hematoma at access site, possibly due to excessive pulling force on the trocar and pedicle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-01385 |
| MDR Report Key | 9892527 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-28 |
| Date of Report | 2020-03-28 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2018-11-30 |
| Date Added to Maude | 2020-03-28 |
| 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 V OSTEO INTRODUCER 13GA TROCAR/BEVEL |
| Generic Name | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Product Code | LXH |
| Date Received | 2020-03-28 |
| Model Number | NA |
| Catalog Number | VPT13D |
| Lot Number | 216656426 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-28 |