MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03,07 report with the FDA on 2014-04-21 for IMPLANT, FIXATION DEVICE, SPINAL manufactured by Synthes (usa).
[4487090]
This report is being filed after the subsequent review of the following journal article: cabrera, e. , alejandro, l. , (2011), preliminary clinical-radiologic results of kyphoplasty and vertebral stenting in the treatment of osteoporotic vertebral fracture, european spine journal, 20:2067-2095. Doi 10. 1007/s00586-011-2013-1. The incidence of vertebral osteoporotic fractures is increasing. It is now the most common osteoporotic fracture and an important public health problem involving considerable healthcare cost. In this study, the preliminary clinical and radiologic results of kyphoplasty with vertebral stenting are reported a retrospective study of 31 patients with a lumbar or lower thoracic vertebral fracture at a single level with posterior wall integrity, treated by kyphoplasty with vertebral body stenting. Mean age was range was 69 through 87 years. Mean follow-up was 12 to 27 months. Complications that was reported are three cases of asymptomatic cement leak occurred and two cases of vertebral fracture in segments adjacent to the treated vertebra. There were no infections or complications. No reoperations were needed. There is not sufficient information to file multiple reports. Cement leakage.
Patient Sequence No: 1, Text Type: D, B5
[11864711]
Cabrera, e. , alejandro, l. , (2011), preliminary clinical-radiologic results of kyphoplasty and vertebral stenting in the treatment of osteoporotic vertebral fracture, european spine journal, 20:2067? 2095. Doi 10. 1007/s00586-011-2013-1. This report is for an unknown vertebral body stenting cement. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2014-10925 |
| MDR Report Key | 3761826 |
| Report Source | 01,03,07 |
| Date Received | 2014-04-21 |
| Date of Report | 2014-04-10 |
| Date Mfgr Received | 2014-04-10 |
| Date Added to Maude | 2014-04-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | IMPLANT, FIXATION DEVICE, SPINAL |
| Product Code | JDN |
| Date Received | 2014-04-21 |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-04-21 |