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 2015-06-19 for ORTHOSIS, SPINE, PLATE, LAMINOPLASTY METAL manufactured by Synthes Usa.
[5873754]
Literature article received: this report is being filed after the subsequent review of the following literature article risk factor analysis of hinge fusion failure after plate-only open-door laminoplasty. Citation: lee, sungjoon (2014). Risk factor analysis of jinge fusion failure after plate-only open-door laminoplasty. Global spine journal, volume number 5, pates 9? 15. ((b)(4)). The purpose of this study was to analyze lamina hinge fusion failure after plate-only open door laminoplasty. Thirty-one patients who underwent the plate-only open-door laminoplasty (total of 110 levels) for cervical myelopathy and who had serial computer tomography (ct) scans at 6 and 12 months were analyzed between (b)(6) 2009 and (b)(6) 2011. Twenty three patients were men and 8 patients were woman. All of the patients in the study had myelopathic symptoms, such as motor weakness, hadn clumsiness, gait disturbance, and sensory abnormalities. The risk factors for fusion failure at 12 months were analyzed. These risk factors included age, sex, smoking, presence of diabetes mellitus and ossification of posterior longitudinal ligament, bone mineral density (t-score), preoperative cervical curvature, operated levels, presence of ventral cortical bony continuity, and reflection angle of the lamina. During the procedure, the patients elevated lamina was fixed with a titanium mini plate (double bended 10- or 12-mm plate) and screws (6 or 8 mm in length) using the synthes arch laminoplasty system. Because the ventral lamina of the hinge side was not identifiable during the operation, the authors regarded the hinge as fractured if the lamina moved freely or if resistance of the hinge was different from the other lamina during the lamina reflecting procedure. No bone graft was interposed in the laminar gap. There were no identifiable lamina hinge fractures in the 31 patients included in the study. The clinical outcomes were assessed with neck pain score using visual analog scale (vas-neck, 10 points), neck disability index (ndi, 50 points), and (b)(4) orthopedic association score (joa, 17 points) at 6 and 12 months postoperatively, and yearly thereafter. This decision tree refers to an unknown arch fixation system and refers to all serious injuries (with the exception of the 1 patient identifier). The serious injuries include the consecutive hinge nonfusion that was observed in 7/31 (22%) of patients at 6 months and 4/31 (12%) patients at 12 months; the 9 patients that did not experience fusion at 6 months post-surgery and 4 total patients did not have fusion at 12 months postoperative; the 22 laminae that experienced no fusion at 6months (2 patients had ventral cortical bony continuity and 20 laminae that did not experience ventral cortical bony continuity); at the 12 month post-operative appointment, 11 laminas did not have fusion (zero of the laminas with ventral cortical bony continuity had nonfusion and 11 of the laminas that did not have ventral cortical bony continuity had non fusion); of the 110 laminae in the study, 21 laminae did not have a ventral cortical bony continuity at 6 months; 10 of the 21 laminae without ventral cortical bony continuity showed fusion at 12 months; and the two laminae (of the 21 lamina without ventral cortical bony continuity at 6 months) that showed depression of 2. 5 and 2. 1mm, respectively, at 6 months with no progression at 12 months. This is report 1 of 2 for (b)(4). This report is for an unknown arch fixation system, unknown part #, unknown lot #.
Patient Sequence No: 1, Text Type: D, B5
[13468370]
Device was used for treatment, not diagnosis. Additional narrative: this report is for an unknown arch fixation system/unknown quantity/unknown lot. Product code xxx was used to capture code nqw, which was not recognized by the system. (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 | 2520274-2015-14461 |
| MDR Report Key | 4855568 |
| Report Source | 01,03,07 |
| Date Received | 2015-06-19 |
| Date of Report | 2015-06-10 |
| Date of Event | 2014-10-10 |
| Date Mfgr Received | 2015-06-10 |
| Date Added to Maude | 2015-06-19 |
| 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 | ORTHOSIS, SPINE, PLATE, LAMINOPLASTY METAL |
| Product Code | NQW |
| Date Received | 2015-06-19 |
| 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 | 2015-06-19 |