MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-08-08 for DISPENSER, CEMENT manufactured by Synthes Usa.
[82056036]
Device used for treatment, not for diagnosis. Scola, a; gebhard, f; schultheiss, m (2010) 5 deutscher wirbelsaulenkongress abstract? Article p87; preliminary clinical results with vertebral body stenting. Eur spine j. 19:1963-2073. This report is for an unknown vertebral body stenting (unknown quantity/unknown lot). The investigation could not be completed; no conclusion could be drawn, as no device was returned and no lot number or part number was provided. (b)(4). 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
[82056037]
This report is being filed after subsequent review of the following literature article: scola, a; gebhard, f; schultheiss, m (2010) 5 deutscher wirbelsaulenkongress abstract? Article p87; preliminary clinical results with vertebral body stenting. Eur spine j. 19:1963-2073. This is a retrospective biomechanical study to show an enhanced reposition of the fracture compared to conventional kyphoplasty. A total of 57 vertebral bodies (19 thoracal, 38 lumbal, th6 till l4) in 53 patients (31 women, 22 men, average age 76,2? 8,9 years) were operated using vertebral body stenting vbs system manufactured by synthes. Forty-five (45) patients had an osteoporotic and 8 patients a pathological fracture. The implantation of the vertebral body stent was possible in all cases. The average height gain in the middle of the vertebral body was 0. 27 cm (sd? 0. 16), anterior 0. 26 cm (sd? 0. 16). The percentage gain in the middle was 21% (sd? 16. 3), anterior 15,3% (sd? 13,3). In one case the stent could not be dilated on one side due to a sclerotic area. In another case the lateral wall of the vertebral body was fractured while dilating the stent. This was not recognized during the operation. There have been no postoperative neurologic problems. The results show that using the vertebral body stenting system a good fracture reposition can be achieved. It is a save system with few complications. This is 1 of 2 for (b)(4). This report is for an unknown vertebral body stenting and refers to the serious injury of 1 unknown patient who experienced the stent could not be dilated on one side due to sclerotic area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2017-12057 |
| MDR Report Key | 6774010 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-08 |
| Date of Report | 2017-07-26 |
| Date Mfgr Received | 2017-07-26 |
| Date Added to Maude | 2017-08-08 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | DISPENSER, CEMENT |
| Product Code | KIH |
| Date Received | 2017-08-08 |
| 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 | 2017-08-08 |