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.
[5806338]
This report is being filed after the subsequent review of the following journal article: chen, y. , et al. (2014). Posterior hybrid technique for ossification of the posterior longitudinal ligament associated with segmental instability in the cervical spine. J spinal disord tech 27:240-244. China. The study objective was to discuss the indications for a posterior hybrid technique for ossification of the posterior longitudinal ligament (opll) associated with segmental instability in the cervical spine and evaluate its effectiveness and safety. Between may 2005 and august 2007, a total of 163 patients required surgical treatment for cervical myelopathy due to opll. Among them, 15 patients (11 males, 4 females) with an age range of (48-73 years) were treated with the posterior hybrid technique (laminoplasty with titanium arch miniplates) and lateral mass screw fixation at the unstable levels (competitor? S product). A total of 17 intervertebral levels in 15 patients (11 mixed-type and 4 continuous-type opll) had segmental instability, which was consistent with the presence of high-intensity zone levels in 10 patients. All patients were followed for at least 4 years (range, 48? 72 mos. ). Before surgery, a detailed radiologic examination was performed to investigate the extent and type of opll, the condition of spinal cord compression and presence of high-intensity zones (hiz). In addition, dynamic x-ray was performed to investigate whether segmental instability was present in the cervical spine. Hiz was present in 12 patients based on preoperative mri. Postoperatively, various scale and test evaluations were used to measure patient outcomes. The patients were also managed with a philadelphia collar for 2 months postoperatively. One patient developed unilateral c5 palsy on the open-door side of the laminoplasty 12 hours postoperatively, and conservative treatment included neurotropic drugs, hyperbaric oxygen therapy, and functional exercises. The strength of involved muscles recovered to grade 4 in manual muscle testing after 2 months. This is report 1 of 1 for (b)(4). This report is for unknown titanium miniplates - arch fixation system, unknown part #/lot #. A copy of the literature article is being submitted with this medwatch.
Patient Sequence No: 1, Text Type: D, B5
[13377020]
Device was used for treatment, not diagnosis. Chen, y. , et al. (2014). Posterior hybrid technique for ossification of the posterior longitudinal ligament associated with segmental instability in the cervical spine. J spinal disord tech 27:240-244 this report is for unknown titanium miniplates - arch fixation system, unknown quantity / unknown lot. (b)(6) (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 | 2520274-2015-14526 |
| MDR Report Key | 4855326 |
| Report Source | 01,03,07 |
| Date Received | 2015-06-19 |
| Date of Report | 2015-06-10 |
| 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 | WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-19 |