MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREW/ROD CONSTRUCT ACCESSORIES; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/ rod construct/ 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 1 of 4 for (b)(4).This report is for the unknown screw/ rod construct.

• Brand Name: UNK - SCREW/ROD CONSTRUCT ACCESSORIES
• Type of Device: THORACOLUMBOSACRAL 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 Key: 9488822
• MDR Text Key: 185492389
• Report Number: 2939274-2019-62708
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/18/2019
• 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