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 2015-01-09 for IMPLANT, FIXATION DEVICE, SPINAL manufactured by Synthes Usa.
[5433793]
This report is being filed after the subsequent review of the following literature abstract: strube, p. , et al (2012). Stand-alone anterior versus anteroposterior lumbar interbody single-level fusion after a mean follow-up of 41 months. Journal of spinal disorders, 25, 362-369. A prospective cohort study comparing evaluations of single-level anterior lumbar interbody fusion (alif) versus anteroposterior lumbar fusion (aplf- other manufacturer device) was conducted to clinically and radiologically compare the outcome after angle-stable, locked, stand-alone alif with that obtained after aplf, in cases with degenerative disc disease (ddd) between march 2005 and april 2007. Eighty patients with chronic low-back pain due to a single-level ddd and facet joint arthritis were enrolled in this study. Forty patients ((19 male, 21 female) received an anteroposterior fusion (alif with transpedicular fixation: aplf group) and 40 patients ((20 male, 20 female) (alif group) were treated with a stand-alone alif using the synfix-lr device. At 7 days, 3, 6, 12, and 24 months, and at a mean follow-up of 41 months, patients were clinically (visual analog scale, oswestry low back pain disability index, satisfaction) and radiologically (x-ray, and at 12 months, thin-slice computed tomography) compared. Visual analog scale and oswestry low back pain disability index improved significantly over time (analysis of variance, p<0. 001) in both groups, but both scores were significantly better in alif group (analysis of variance, p<0. 001). Patients? Satisfaction consistently ranked higher in the alif group (p=0. 042 at 12 mos). No significant difference was found in the fusion rate throughout the study. At final follow-up, 66 patients (82. 5%; 34 patients in alif and 32 in aplf group) were available for analysis. One patient died because of a carcinoma of the colon and another because of a carcinoma of the lung. One patient of the alif group had a revision surgery adding posterior stabilization after 1 week. A patient in the alif group presented a clinically asymptomatic dislocation of the synfix-lr cage, together with a breakout of the screws in the surgically treated segment, in a routine radiographic control at 7 days. Reevaluation of the preoperative radiographs and mri revealed a bilateral spondylolysis, which led to implant failure and spondylolisthesis after surgical destabilization. Also, a third patient reported persisting temperature difference between her feet with intermittent paresthesia of the left leg, due to intraoperative damage of the sympathetic nervous system. This report is against a synfix-lr cage regarding temperature fluctuations in lower extremities and paresthesia. This is report 2 of 4 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12647021]
The device was used for treatment, not diagnosis. This report is for an unknown synfix-lr device with unknown lot number and unknown quantity. (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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2015-10084 |
| MDR Report Key | 4404190 |
| Report Source | 01,03,07 |
| Date Received | 2015-01-09 |
| Date of Report | 2014-12-10 |
| Date Mfgr Received | 2014-12-10 |
| Date Added to Maude | 2015-01-09 |
| 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 | 2015-01-09 |
| 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 | 2015-01-09 |