• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WRIGHTS LANE SYNTHES USA PRODUCTS LLC PLATE,FIXATION,BONE Back to Search Results
Device Problem No Apparent Adverse Event (3189)
Patient Problem Arthritis (1723)
Event Date 07/01/2015
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. 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).
 
Event Description
This report is being filed after the review of the following journal article: amini, mh. Et al (2015), comparison of outcomes and costs of tension-band and locking-plate osteosynthesis in transverse olecranon fractures: a matched-cohort study, the american journal of orthopedics, vol. 44(7), pages e211-e215 (usa). Https://uthsc. Pure. Elsevier. Com/en/publications/comparison-of-outcomes-and-costs-of-tension-band-and-locking-plat. The purpose of this retrospective study is to determine the significant differences in outcomes and costs between tension-band and locking-plate fixation of the transverse olecranon fractures in adults. Between 2004 and 2011, a total of 20 patients underwent fixation of an isolated, transverse, non-comminuted olecranon fracture. 10 patients with a mean age of 51. 7 years were treated with tension-band fixation and another 10 patients with a mean age of 55. 2 years were treated locking-plate constructs. Of these locking-plates, 3 were unknown synthes locking compression plate. All patients were reached at minimum 2-year follow-up. The following complications were reported as follows: 1 locking-plate patient required implant removal. 3 locking-plate patients had radiographic evidence of grade 1 posttraumatic arthrosis. These patients had slightly less flexion. 3 locking-plate patients had implant-related symptoms or implant prominence. This report is for an unknown synthes locking compression plate. This is report 1 of 4 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8748641
MDR Text Key149653641
Report Number2939274-2019-58931
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received06/04/2019
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: 07/01/2019 Patient Sequence Number: 1
-
-