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 2015-04-07 for IMPLANT, FIXATION DEVICE, SPINAL manufactured by Synthes Usa.
[5608356]
Abstract received: this report is being filed after the subsequent review of the following literature abstract: zhang, zj, et al. (nov 2011). Treatment of thoracolumbar burst fracture with lateral anterior decompression, internal fixation with ventrofix and bone graft with titanic mesh. China j orthop trauma. 24, 955-957. The objective of this literature was to discuss the efficacy of lateral anterior decompression, internal fixation with ventrofix and bone graft with titanic mesh in the treatment of severe thoracolumbar burst fracture. From january 2008 to january 2010, 21 patients with severe thoracolumbar burst fracture were treated with lateral anterior decompression, internal fixation with ventrofix, bone graft with titanic mesh. There were 15 males and 6 females, ranging in age from 21 to 46 years with an average of 32. 2 years. Segment of fracture: 3 cases were in t 11, 6 cases in t 12, 7 cases in l 1, 5 cases in l 2. The mean kyphosis angle was 20. 1? And loading of fracture was 7. 8 scores. Twenty one cases accompany with incomplete paralysis. Nerves functions were observed according to frankel grade; correction and maintain of kyphosis angle were observed by x-rays and computed tomography. All the patients were followed up from 12 to 34 months with an average of 18. 5 years. Postoperative complication including injury of pleura in 1 case, dynamic ileus in 2 cases, ilioinguinal nerve injury in 1 case, faulty union of wound in 1 case. All the above complications got recovery after symptomatic treatment. The mean kyphosis angle in fusional segment was 4. 2? And the rate of correction was 79%. Nerves functions of all patients got improvement and no internal fixation fail, kyphosis angle obviously lost, titanium mesh shifting, loosening and breakage of screw were found at final follow-up. This report is for the ventrofix system concerning adverse events that included: injury of pleura (1), dynamic ileus (2), ilioinguinal nerve injury (1), and faulty union of wound (1). This is report 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13275422]
Device was used for treatment, not diagnosis. This report is for unknown ventrofix system/unknown lot. (b)(6). (b)(4). The investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2015-12151 |
| MDR Report Key | 4665269 |
| Report Source | 01,03,07 |
| Date Received | 2015-04-07 |
| Date of Report | 2015-03-16 |
| Date Mfgr Received | 2015-03-16 |
| Date Added to Maude | 2015-04-07 |
| 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 | 2015-04-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2015-04-07 |