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 2015-06-18 for IMPLANT, FIXATION DEVICE, SPINAL manufactured by Synthes (usa).
[5946381]
This report is being filed after the subsequent review of the following literature article: zhou, d. , & et al. Application of lamina replantation with arch plate fixation in thoracic and lumbar intraspinal tumors. Experimental and therapeutic medicine 6: 596-600. The goal of this study was to investigate the clinical effects of lamina replantation with arch (synthes) plate fixation on patients with thoracic and lumbar intraspinal tumors, following laminectomy. Thirteen patients with thoracic and lumbar intraspinal tumors underwent total lamina replantation with arch plate fixation and repair of the supraspinous ligaments, following laminectomy and tumor enucleation. There were 8 females and 5 males with an age range of 28 to 52 years. To investigate the clinical effect of lamina replantation with arch plate fixation, pre and postoperative visual analog scale (vas), and oswestry disability index (odi) scores were determined, and pre and postoperative x-ray and magnetic resonance imaging (mri) examinations were conducted. Computed tomography (ct) examinations were also included in the follow up. The vas and odi results 2 weeks following surgery and at the final follow up examination demonstrated a significant improvement compared with the corresponding preoperative results. The x-ray examination results indicated a satisfactory internal fixation location, without any characteristics of a fracture, lumbar scoliosis, kyphosis or instability. Following the surgery, the ct and mri examination results demonstrated that healing of the lamina bone and repair of the supraspinous ligament had occurred without tumor recurrence or spinal epidural scar recompression. One patient developed postoperative cerebral spinal fluid leakage and spontaneously recovered following conservative treatment. Two of the 13 cases were lost to follow-up. The results indicated that in patients with thoracic and lumbar intraspinal tumors, lamina replantation with arch plate fixation following total laminectomy is effective and provides thoracolumbar stability. This report is for an unknown arch system concerning one patient with a cerebral spinal fluid leak. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13498228]
Device was used for treatment, not diagnosis. This report is for 1 unknown arch system/unknown part and lot numbers. Reporter: (b)(6). The investigation could not be completed and no conclusion could be drawn, as no device was returned and no part or lot 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 | 2520274-2015-14452 |
| MDR Report Key | 4852459 |
| Report Source | 01,03,07 |
| Date Received | 2015-06-18 |
| Date of Report | 2015-06-10 |
| Date Mfgr Received | 2015-06-10 |
| Date Added to Maude | 2015-06-18 |
| 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 | 2015-06-18 |
| 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 | 2015-06-18 |