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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES PLATE, FIXATION, BONE Back to Search Results
Device Problem Migration (4003)
Patient Problems Pain (1994); Pocket Erosion (2013); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
There are multiple patients. All known information is provided in the literature article. This report is for an unknown plate/unknown lot. Part and lot number are unknown; udi number is unknown. There are multiple unknown dates of implantation between august 2008 to december 2015. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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).
 
Event Description
This report is being filed after the review of the following journal article:bazarov i. , et al (2018),minimally invasive plate osteosynthesis for treatment of ankle fractures in high-risk patients ,the journal of foot & ankle surgery, volume 57 ,pages 494¿500 (usa). This study aims to report our experience using minimally invasive plate osteosynthesis (mipo) in the management of unstable ankle fractures in elderly patients, patients with a compromised soft tissue envelope, and those with medical comorbidities. From august 2008 to december 2015, a total of 44 patients (10 male and 34 female) age <60
=
60 who had undergone surgical treatment of unstable ankle fractures using mipo technique were included in the study. All patients had received fixation with a combination of synthes plates and screws using the mipo technique most patients were followed up in the clinic at 10 to 14 days, 6 weeks, 8 weeks, and 3 months postoperatively. The mean follow-up period was 82 (range 52 to 293) weeks. The following complications were reported: complications occurred in 12 patients (27%). Eleven patients (25%) developed surgical wound dehiscence. Of these 11 patients, 7 healed with local wound care alone, and 1 developed a superficial infection and was successfully treated with oral antibiotics. 1 patient had superficial infection. 3 cases of deep infection. 8 patients had additional surgery. 3 patients had exposed hardware and required hardware removal and intravenous antibiotics. Hardware failure and loss of reduction occurred in 5 patients (11%). Of these 5 patients, 1 patient was treated with bracing, the syndesmotic screws were exchanged at 4 weeks postoperatively in 1 patient, and 3 patients developed significant ankle pain and eventually required ankle fusion. 7 patients died. This report is for an unknown synthes plate. This is report 3 of 4 for (b)(4).
 
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Brand NameUNK - PLATES
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key9082155
MDR Text Key163196288
Report Number2939274-2019-60671
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 08/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/18/2019 Patient Sequence Number: 1
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