MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES: PROXIMAL TIBIA PLATE; BONE PLATE

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate / unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.(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).

Event Description

This report is being filed after the review of the following journal article: yaowei z., jiabing x., guozheng d.,(2018), effects of expanded anterolateral approach for tibial plateau fractures involved the posterolateral column, natl med j china, volume 98, number 5, pages 352-356 (china).This retrospective study aims to explore the short-term effects of expanded anterolateral approach in treating fracture involved the posterolateral tibial plateau.From january 2013 to july 2016, a total of 16 patients (11 male and 5 female) aged 25 years to 71 years, mean (47) years, who were treated for posterolateral tibial plateau fracture were included in the study.Fixation was done using 3.5 mm inverted "l" type proximal tibial locking compression steel plate (product of swiss company synthes gmbh).All patients in the group received follow-up for 12 months to 16 months, with 13.1 months on average.The following complications were reported as follows: the anatomic reduction was not achieved in two cases and steps 2 mm were left in these 2 cases.1 patient had a fair score in the modified rasmussen knee score at follow-up.This report is for an unknown synthes proximal tibial locking compression steel plate this is report 1 of 2 for (b)(4).

• Brand Name: UNK - PLATES: PROXIMAL TIBIA PLATE
• Type of Device: BONE PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9008979
• MDR Text Key: 158145783
• Report Number: 8030965-2019-68213
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention