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 2015-01-07 for IMPLANT, FIXATION DEVICE, SPINAL manufactured by Synthes Usa.
[5436301]
This report is being filed after the subsequent review of the following literature abstract: horsting, p. , et al (2011). Peek-cages in lumbar fusion: mid-term clinical and radiological outcome. From december 2004 until august 2007, a total of 95 patients (21 double level, 74 single level) with degenerative disc disease from l3 to s1 were operated on. The primary outcome measure was re-operation. Secondary outcome measures were bony bridging within the cage based on ct-scan and clinical improvement measured by the oswestry score. The median duration of follow-up was 47. 7 months (range 29. 9? 61. 6 months). In total 24 patients (25. 3%) were re-operated after a mean of 21. 9 months (range 6. 7-46. 9) of the initial surgery. Twenty-three patients (18 single-level, 5 double-level) were re-operated for symptomatic pseudarthrosis and one patient for a deep wound infection. In one double-level patient both levels were pseudarthrotic. A ct scan was performed in 89 patients (109 out of 116 levels; 94%); 43 levels (39. 4%) in 41 patients were pseudarthrotic. The mean oswestry score improved from 28. 1 to 16. 0. No relation has been found between the oswestry score and radiological outcome in this population. In this review, a high number of reoperations after an anterior lumbar interbody fusion (alif) procedure with the synfix-lr cage was found, mainly due to pseudoarthrosis. In the opinion of the authors, the absence of posterior fixation may have lead to insufficient initial stability, creating suboptimal conditions for bony bridging, and thus solid fusion. This report is against an unknown number of synfix-lr cages regarding pseudarthrosis and a deep wound infection.
Patient Sequence No: 1, Text Type: D, B5
[12736537]
The device was used for treatment, not diagnosis. Horsting, p. , et al (2011). Peek-cages in lumbar fusion: mid-term clinical and radiological outcome. This report is for unknown synfix-lr cages/unknown quantity/unknown lot number. (b)(6). 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 | 2520274-2015-10075 |
| MDR Report Key | 4390277 |
| Report Source | 01,03,07 |
| Date Received | 2015-01-07 |
| Date of Report | 2014-12-10 |
| Date Mfgr Received | 2014-12-10 |
| Date Added to Maude | 2015-01-07 |
| 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 | 2015-01-07 |
| 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 | 2015-01-07 |