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 2017-09-21 for ROD manufactured by Synthes Usa.
[87210092]
This report is for an unknown nflex system (unknown quantity/unknown lot). (other number) udi: unknown part number, udi is unavailable. 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. 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
[87210093]
This report is being filed after subsequent review of the following literature article: lee, s; jahng, t; kim, h; (2016) clinical experiences of non-fusion dynamic stabilization surgery for adjacent segmental pathology after lumbar fusion. Int. Journal of spine surgery, vol 9 (8), 13 pages. This is a retrospective study to review an alternative to spinal fusion, non-fusion dynamic stabilization surgery has been developed, showing good clinical outcomes. In the present study, we introduce our surgical series, which involves non-fusion dynamic stabilization surgery for adjacent segment pathology (asp) after lumbar fusion surgery. Two types of pedicle-based dynamic stabilization systems were applied: the dynesys system and the nflex system (synthes spine, inc. ). From 2003 to 2011, 15 patients with symptomatic aggravation and radiologic confirmation of asp after previous lumbar fusion surgery had undergone the non-fusion dynamic stabilization. There were 13 females and 2 males, the mean age was 56. 2? 6. 9 years (range, 43-67) upon the prior fusion surgery, 62. 1? 6. 4 years (range, 46-70) upon the non-fusion surgery, and 68. 5? 6. 8 years (range, 52-77) at the final follow-up. The dynesys system was used on eleven patients while the nflex system was used on four patients. Pain was measured by the visual analog scale (vas, 0-10) and functional outcome was assessed by the (b)(6) version of oswestry disability index. Three patients had persistent pain after their non-fusion surgery, and four patients of which 2 used nflex (26. 6%) had a relapse of pain in the back and legs after a mean of 30 months after non-fusion surgery (30. 0? 11. 3 months, range, 20-43). Persistent pain after the fusion and non-fusion surgeries, as well as relapsed pain after the non-fusion surgery, did not affect the differences in both the vas and odi values (all p > 0. 05). No patient underwent additional surgery for asp after undergoing non-fusion dynamic stabilization surgery. A copy of the literature article will be submitted with the medwatch. This report is 1 of 2 for (b)(4). This report is for an unknown nflex system and refers to the serious injury of patient number 13, (b)(6) female, who experienced had relapse of pain in the back and legs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2017-12312 |
| MDR Report Key | 6882737 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-09-21 |
| Date of Report | 2017-09-19 |
| Date of Event | 2016-02-03 |
| Date Mfgr Received | 2017-09-19 |
| Date Added to Maude | 2017-09-21 |
| 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 | 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 | ROD |
| Product Code | NQP |
| Date Received | 2017-09-21 |
| 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 | 2017-09-21 |