• 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 UNK - SCREWS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

  • 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 UNK - SCREWS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Thrombosis (2100); Injury (2348); Non-union Bone Fracture (2369); Blood Loss (2597)
Event Type  Injury  
Manufacturer Narrative
This report is for unknown spine screw/ unknown lot. Part and lot numbers 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. 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: freudenberger, c et al (2009), posterior versus anterior lumbar interbody fusion with anterior tension band plating: retrospective analysis, orthopedics, volume 32, number 7, pages 1-6, (usa). The purpose of the present study was to retrospectively compare the outcomes of anterior lumbar interbody fusion (alif) with plate fixation to the accepted posterior lumbar interbody fusion (plif) with pedicle screw instrumentation, with regard to surgical time, blood loss, radiographic evidence of fusion, and function. Between 2004 and 2006, 59 patients with 1- or 2-level lumbar degenerative disk disease from l3 to s1 who underwent surgical treatment were included in the study. 29 patients, composed of 11 men and 18 women with a mean age of 58+/-14 years, underwent plif with unknown pedicle screw instrumentation. Meanwhile, the 30 patients, composed of 11 men and 18 women (1 patient with missing sex identification) with a mean age of 40+/-8 years, had an alif with anterior plating using an unknown synthes anterior tension band plate. Lumbar bracing was provided for the first 6 weeks postoperatively and activity advancement was based on progress in the physical therapy regimen. Complications were reported as follows: 2 patients displayed minimal fusion at 6 to 9 months postoperative radiographic analysis. 9 patients displayed partial fusion at 6 to 9 months postoperative radiographic analysis. 2 patients had intraoperative common iliac vein injuries and repairs (estimated blood loss 800 and 1000). 1 patient had postoperative thrombus. 1 patient had ileus. This is report 4 of 4 for (b)(4). This report is for the unknown spine screws.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNK - SCREWS
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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 Key9489054
MDR Text Key185522308
Report Number2939274-2019-62711
Device Sequence Number1
Product Code NKB
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 12/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2019
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 Received12/02/2019
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: 12/18/2019 Patient Sequence Number: 1
-
-