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 2017-04-26 for TRACTION, COMPONENT, INVASIVE manufactured by Synthes Usa.
[73716126]
Device was used for treatment, not diagnosis. Wiznia, d. H. , et al (2016) a method of using a pelvic c-clamp for intraoperative reduction of a zone 3 sacral fracture. Hindawi publishing corporation, case reports in orthopedics, volume 2016, article id 8586517, 5 pages. This report is for unknown pelvic c-clamp, unknown quantity, unknown lot. 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. 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
[73716127]
Literature article received. This report is being filed after the subsequent review of the following literature article: wiznia, d. H. , et al (2016) a method of using a pelvic c-clamp for intraoperative reduction of a zone 3 sacral fracture. Hindawi publishing corporation, case reports in orthopedics, volume 2016, article id 8586517, 5 pages. A (b)(6)-year-old man suffered a pelvic ring injury and a comminuted proximal humerus fracture-dislocation in a motorcycle collision. A pelvic c-clamp was then applied over the s2 transsacral wire. Radiographs demonstrated an anatomic reduction. With the c-clamp holding the sacral fracture reduction, s1 transsacral screw was engaged into the far ilium allowing for more compression across the fracture site. An additional guide wire was passed at the s2 level for further stability. Another transsacral screw was placed across the fracture utilizing one of the s2 guide wires. The patient? S hospital course was complicated by pneumonia and a deep vein thrombosis. The patient was discharged to short term rehabilitation on hospital day 30, with restrictions not to bear more than 25 pounds to the left lower extremity. At the patient? S 8-week follow-up appointment, he complained of burning and numbness over the buttocks. At the patient? S three-month follow-up, he complained of sacral and bilateral buttock pain, as well as sexual dysfunction. At a recent 3-year follow-up the patient is weight bearing as tolerated without restriction. He has returned to motorcycling. This is report 1 of 1 for (b)(4). This report is for an unknown pelvic c-clamp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2017-11526 |
| MDR Report Key | 6522393 |
| Report Source | COMPANY REPRESENTATIVE,LITERA |
| Date Received | 2017-04-26 |
| Date of Report | 2017-03-31 |
| Date Mfgr Received | 2017-03-31 |
| Date Added to Maude | 2017-04-26 |
| 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 | TRACTION, COMPONENT, INVASIVE |
| Product Code | JEC |
| Date Received | 2017-04-26 |
| 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 | 2017-04-26 |