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 2019-05-28 for APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR manufactured by Oberdorf Synthes Produktions Gmbh.
[146276343]
Brand name, common device name, procode, mfr, lot #, part #, udi #, 510k: this report is for an unknown dynamic hip screw (dhs). /unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). Device evaluated by mfr, manufacture date: without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[146276344]
This report is being filed after the review of the following journal article: pajarinen, j. Et al (2005), pertrochanteric femoral fractures treated with a dynamic hip screw or a proximal femoral nail, the journal of bone and joint surgery (br), vol. 87-b no. 1, page 76-81 (finland). The purpose of this retrospective study is to assess the patients? Recovery after operative treatment of a pertrochanteric femoral fracture with either dhs or pfn, in a randomized, prospective series of 108 patients. Between october 1999 and february 2001, a total of 108 patients (27 male and 81 female) were included in the study. Fracture fixation was fixed using unknown synthes dynamic hip screw (dhs) or unknown synthes proximal femoral nail (pfn). Follow-up reviews were undertaken at 6 months and 4 months postoperatively. The following complications were reported as follows: 2 patients died in the immediate post-operative period from cardiovascular causes. Another 4 died before completion of the follow-up. 2 cases of redisplacement of the fracture in both groups. 4 patients had revision operations. 1 case of heterotopic ossification, corresponding to pfn had been used. A (b)(6) female had not good primary reduction and screw cut-out. A (b)(6) female had good primary reduction and screw cut-out. An (b)(6) had not good primary reduction. A (b)(6) male had not good primary reduction. This report captures adverse events of surgical intervention, heterotopic ossification and re-displacement. This report is for an unknown synthes dynamic hip screw (dhs). This is report 1 of 6 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-64607 |
| MDR Report Key | 8647148 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-28 |
| Date of Report | 2019-04-29 |
| Date of Event | 2005-01-05 |
| Date Mfgr Received | 2019-04-29 |
| Date Added to Maude | 2019-05-28 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR |
| Product Code | JDO |
| Date Received | 2019-05-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2019-05-28 |