MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-10-04 for UNK manufactured by Medtronic Sofamor Danek Usa, Inc..
[169743550]
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
[169743551]
Total patients involved: 141 (30 male and 111 female), age: 73. 3+/-9. 5 years (mean age), weight-65. 4+/-12. 1 kg, height-1. 62+/-00. 9. It was reported via literature titled "a prospective, international, randomized, noninferiority study comparing an implantable titanium vertebral augmentation device versus balloon kyphoplasty in the reduction of vertebral compression fractures (sakos study)" a total of 141 patients (30 male and 111 female) in which 68 patient underwent titanium vertebral augmentation device(tivad) and 73 underwent balloon kyphoplasty(bkp). Adverse events were similar for both groups (41. 2% in the tivad group and 45. 2% in the bkp group). The most frequent serious adverse event were lumbar vertebral fractures (six patients with tivad; five patients with bkp) and thoracic vertebral fractures (four patients with tivad; seven patients with bkp). Aes related to procedure (non-serious events): thoracic vertebral fracture in five patients with bkp; non-serious rib fracture in one patient with tivad. The incidence of adjacent fractures was significantly lower after the tivad procedure than after bkp. Asymptomatic cement extravasation and balloon ruptured occurred in both the groups. No patient required surgical re-intervention or re-treatment at the treated level. Adverse events: adjacent fractures, lumbar vertebral fractures and thoracic vertebral fractures. Conclusion: study results demonstrated non-inferiority of the tivad to the predicate bkp with an excellent risk/benefit profile for results up to 12 months.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2019-01116 |
| MDR Report Key | 9155212 |
| Report Source | LITERATURE |
| Date Received | 2019-10-04 |
| Date of Report | 2019-10-04 |
| Date Mfgr Received | 2019-09-04 |
| Date Added to Maude | 2019-10-04 |
| 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 | 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 | 2019-10-04 |
| 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 | 1. Other | 2019-10-04 |