MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: VEPTR; PROSTHESIS, RIB REPLACEMENT

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient information: there are multiple patients.All known information is provided in the literature article.Brand name, common device name, procode, mfr, lot #, part #, udi #, 510k #: this report is for an unknown veptr construct/unknown lot.Part and lot number are unknown; udi number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr, manufacture date: 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: matsumoto, h., et al (2017), patients undergoing casting for early-onset scoliosis experience decreases in short-term health-related quality of life, scoliosis and spinal disorders, volume 12(s-1) page 21 of 43 (usa) doi 10.1186/s13013-017-0124-0 this retrospective study aims to describe the changes in hrqol and family burden of patients with eos who underwent treatment with surgery or casting.A total of 40 patients who were treated with surgery or serial casting were included in the study.Out of these patients, 8 idiopathic and 49 non-idiopathic patients were surgically treated using a vertical expandable prosthetic titanium rib and growing rod instrumentation.Follow up was done at 6 months to 1 year after treatment.The following complications were reported: seventeen surgical patients presented with post-operative complications: 12 non-idiopathic patients had minor complications (complications not necessitating re-operation); 3 non-idiopathic patients had major complications (complications necessitating re-operation); 2 idiopathic patients had minor complications.This report is for an unknown synthes vertical expandable prosthetic titanium ribs (veptr) construct.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: VEPTR
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• 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: 8888682
• MDR Text Key: 154267944
• Report Number: 2939274-2019-59797
• Device Sequence Number: 1
• Product Code: MDI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/16/2019

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: 07/16/2019
• Initial Date FDA Received: 08/13/2019
• 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