MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-04-20 for TRACTION, COMPONENT, INVASIVE manufactured by Synthes Usa.
[73235786]
Device was used for treatment, not diagnosis. Heini, p. F. , witt, j. And ganz, r. The pelvic c-clamp for the emergency treatment of unstable pelvic ring injuries. A report on clinical experience of 30 cases. This report is for unknown ao 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. (b)(4). 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
[73235787]
Literature article received. This report is being filed after the subsequent review of the following literature article: heini, p. F. , witt, j. And ganz, r. The pelvic c-clamp for the emergency treatment of unstable pelvic ring injuries. A report on clinical experience of 30 cases. An unstable pelvic ring injury was stabilized with the a0 c-clamp in thirty multiply injured patients. In 66% of cases, the initial reduction was good and the anatomy of the pelvic ring was adequately restored. Ten patients (33%) died (unrelated to ao c-clamp); five during the first hours after admission due to haemorrhagic shock; the remaining five from multiple organ failure, fat embolism and head injury. Clamp related problems: loss of reduction of the fracture dislocation and loosening of the clamp was observed in four patients: patient 8, (b)(6). This is report 1 of 4 for (b)(4). This report is for unknown ao c-clamp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2017-11409 |
| MDR Report Key | 6506985 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-04-20 |
| Date of Report | 2017-03-27 |
| Date Mfgr Received | 2017-03-27 |
| Date Added to Maude | 2017-04-20 |
| 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 | 2017-04-20 |
| 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 | 2017-04-20 |