MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: USS; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problems Inflammation (1932); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients, all information is provided in the article.This report is for unknown uss constructs/unknown lot.Part and lot numbers are unknown; udi number is unknown.Implant date is between (b)(6) 2001 to (b)(6) 2003.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.(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: villarraga, m.L.Et al (2005), wear and corrosion in retrieved thoracolumbar posterior internal fixation, spine, vol.31 (21), pages 2454-2462 (usa).The aim of this study is to evaluate retrieved spinal instrumentation systems from a group of patients in an urban clinical setting.Between september 2001 to august 2003, a total of 57 patients (18 male and 39 female) with an average age at implantation range from 13.7-77.4 years (mean +/- sd, 43.9 +/-15.4) were included in the study.Of their patients, only 5 percent were implanted with universal spine system (uss; synthes spine).The following complications were reported as follows: retrieval diagnosis were pseudoarthrosis in 46%, back pain in 37%, radiculopathy in 19%, prominent instrumentation in 19%, scoliosis in 16%, inflammation in 14%, loose instrumentation in 11%, kyphosis in 7%, spondylolisthesis in 7%, herniated disc in 7%, instrument fracture in 7%, myelopathy in 2%, tumor in 2% and elective in 2%.2 patients had fatigued screws.1 of these had pseudarthrosis as a retrieval diagnosis (figure 1).2 patients had fatigued rods.1 of these had pseudarthrosis as a retrieval diagnosis (figure 1).Wear was identified in 75% of the implants, corrosion in 39%, and scratches were identified in 81%.There was no evidence of corrosion in any of the titanium implants, but corrosion was present, along with wear, in 58% of the stainless-steel implants (47% of short and 67% of long stainless-steel implants).We observed evidence of wear in the titanium implants, specifically in 62% of the ti-6al-4v implants and in 88% of the cp-ti implants (table 3).This report is for an unknown synthes uss construct.A copy of the literature article is being submitted with this medwatch.This is report 1 of 7 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: USS
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• 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: 9199151
• MDR Text Key: 162787226
• Report Number: 2939274-2019-61610
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• 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: 09/26/2019
• 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