MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2020-03-20 for UNK - CONSTRUCTS: EXPERT TIBIAL NAIL manufactured by Oberdorf Synthes Produktions Gmbh.
[188984455]
There are multiple patients all information is provided in the article. Implant date is between 2009 and 2012. This report is for an unknown constructs: expert tibial nail/unknown lot. Part and lot number are unknown; udi number is unknown. 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. 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. (b)(4). 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
[188984456]
This report is being filed after the review of the following journal article: ladurner a. , acklin y. , mueller t. , sommer c. , (2019) decrease surgery time by using an alternative lateral parapatellar approach for tibia shaft fracture nailing , archives of orthopaedic and trauma surgery, volume 139, pages 943? 949 (switzerland). This retrospective study aims to assess whether the medial parapatellar, transpatellar and lateral parapatellar approaches differ in those aspects of surgical management. Between 2009 and 2012, all patients treated by intramedullary tibial nailing through either a transpatellar, a medial parapatellar or a lateral parapatellar approach for tibial shaft fractures ao type 42 a? C were reviewed. A total of 73 (40 males and 33 females) patients with overall mean age of 44 years met the inclusion criteria and were included in the study. All fractures were treated using the expert tibial nail (synthes? , oberdorf, switzerland). The patients were followed up at a minimum of 1 year. The following complications were reported as follows: (overall complication occurred in 6 of 73 patients). One patient suffered wound-healing problems without operative revision. Four patients underwent revision surgery because of malalignment of the fracture, one patient suffered from superficial and one from deep wound infection needing revision. One deep infection was seen with the transpatellar approach, and a superficial infection occurred in the lateral approach group. This report is for an unknown synthes expert tibial nail. This report is for one unknown constructs: expert tibial nail. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-02153 |
| MDR Report Key | 9861457 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-03-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHT 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 |
| Brand Name | UNK - CONSTRUCTS: EXPERT TIBIAL NAIL |
| Generic Name | NAIL,FIXATION,BONE |
| Product Code | JDS |
| Date Received | 2020-03-20 |
| 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 | 2020-03-20 |