MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,litera report with the FDA on 2017-10-31 for SURGICAL MESH manufactured by Synthes Usa.
[91937908]
Device used for treatment, not for diagnosis. Lau (2012). Radiological outcomes of static vs expandable titanium cages after corpectomy: a retrospective cohort analysis of subsidence. Neurosurgery, volume 72(4) , pages 529-539. This report is for an unknown synmesh (synthes, west chester, pennsylvania). (other number) udi: unknown part number, udi is unavailable. The investigation could not be completed; 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
[91937909]
This report is being filed after the subsequent review of the following literature article: lau (2012). Radiological outcomes of static vs expandable titanium cages after corpectomy: a retrospective cohort analysis of subsidence. Neurosurgery, volume 72(4) , pages 529-539. The purpose of the study was to assess whether subsidence rates differ between static and expandable cages and also identify independent risk factors for subsidence and extent of subsidence when present. A total of 91 patients who underwent corpectomy cage placement between 2006 and 2009 were identified. Reconstruction of the corpectomy defect was done by placement of either a static cage in 51 patients (51/91) or an expandable cage in 40 patients (40/91). A variety of cages were used from different manufacturers. Static cage, synmesh (synthes, west chester, pennsylvania) was placed in 1 patient (1/91) and expandable cage, synex (synthes, west chester, pennsylvania) was placed in 3 patients (3/91). All 91 patients could be assessed at the 1-month postoperative follow-up, and 62/91 patients could be assessed at the 1-year follow-up. A threshold of 2 mm was used to establish the presence of subsidence in this study. Based on the information provided in the table 3 in the article, there is no reported subsidence in patients with expandable cage, synex (synthes, west chester, pennsylvania). In patients with static cages, in 17/40 patients had the mean subsidence of 4. 1 mm at 1 month follow up and 15/40 patients had mean subsidence of 5. 2 mm at 1 year follow up. This report is for an unknown synmesh (synthes, west chester, pennsylvania). This report is for one (1) device. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2017-12567 |
| MDR Report Key | 6991272 |
| Report Source | COMPANY REPRESENTATIVE,LITERA |
| Date Received | 2017-10-31 |
| Date of Report | 2017-10-10 |
| Date of Event | 2012-12-14 |
| Date Mfgr Received | 2017-11-14 |
| Date Added to Maude | 2017-10-31 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SURGICAL MESH |
| Product Code | EZX |
| Date Received | 2017-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-10-31 |