MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-12-05 for TRACTION,COMPONENT,INVASIVE manufactured by Oberdorf : Synthes Produktions Gmbh.
[93802860]
Patient identifier, date of birth, and weight not available for reporting. Date of death is unknown. Date of event: unknown. Pma / 510k: this report is for an pelvic c-clamp/unknown lot. Part and lot numbers are unknown; udi number is unknown. Device is an instrument and is not implanted/explanted. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. Device was used for treatment, not diagnosis. 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
[93802861]
This report is being filed after the subsequent review of the following literature article kim. W-y. , lee. S-w. , kim. K-s. , lee. J-y. (2017). Superior gluteal artery pseudoaneurysm caused by pelvic c-clamp blind application: a case report. Hip & pelvis, 29(2), p. 145-149. (b)(6). The purpose of the article is to further demonstrate the life-threatening results of blind c-clamp procedures in emergency situations. The article is a case report telling the story of a (b)(6)-year-old man who was rushed to the hospital after being in a motor vehicle accident. Initial x-ray and pelvic computed tomography (ct) scan showed diastasis of the symphysis pubis and right sacroiliac joint. As well as fractures of the superior and inferior rami, and the right hemipelvis was externally rotated. Associated injuries were multiple rib fractures and hemothorax. In addition to these reported injuries, it is believed that the patient was under hypovolemic shock, due to his low hemoglobin level, his 60/40 mmhg blood pressure and his 150 beats/minute pulse rate. Upon entering the hospital, the patient was intubated and further resuscitated with lactated ringer? S solution and packed red blood cells. It is believed that this situations urgency is the cause of the pelvic ring stabilization being obtained blindly using a c-clamp (ao pelvic c-clamp ) in the emergency room. After the patient? S vital signs stabilized, it was discovered in a radiograph that the pelvic c-clamps were misplaced at the left superoposterior bony surface of the acetabulum. The patient was able to recover from his state of hemorrhagic/hypovolemic shock. Extubation was done the day after admission. The surgery was scheduled five days after the trauma. The pin site oozing was increased four days after the trauma, the pins of pelvic c-clamp became more loosened. The c-clamp was removed on the scheduled operation date. The patient was put under anesthesia including intubation and an ilioinguinal approach was used on supine position to perform an open reduction and internal fixation of the diastasis symphysis pubis and pubic rami fracture. The diastasis of the right sacroiliac joint was also reduced and fixed using two sacroiliac screws that were tightly locked over the sacrum. Exsanguinate bleeding from the pelvic floor persisted, but was thought to be bleeding from the fracture site and the operation was completed. The operation time was three and half hours. On the first day following the procedure the patient? S hemoglobin and blood pressure began to drop. Angiography was performed of the common iliac artery, internal and external right iliac arteries, and their branches. Angiography revealed a pseudoaneurysm of the left superior gluteal artery. The aneurysm was immediately embolized. Unfortunately, the patient? S vital signs continued to drop and he eventually passed away. This is report 1 of 1 for (b)(4). This complaint involves 1 part (an unknown c-clamp).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2017-50316 |
| MDR Report Key | 7083981 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-05 |
| Date of Report | 2017-11-07 |
| Date Mfgr Received | 2017-11-07 |
| Date Added to Maude | 2017-12-05 |
| 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 | 2017-12-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF : SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-12-05 |