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 Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unk - constructs: veptr/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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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.

Event Description

This report is being filed after the review of the following journal article: klyce, w.Et al (2020), characterizing use of growth-friendly implants for early-onset scoliosis: a 10-year update, journal of pediatric orthopedics, vol.40 (8), pages e740¿e746 (usa).The aim of this study is to analyze data from the pediatric spine study group database to provide a 10-year update on findings from the previous study, and sought to characterize changes in the relative distributions of growth-friendly constructs over time and the incidence and mean age at ¿final¿ fusion (ie, a permanent surgical fusion performed in patients deemed to have ¿graduated¿ from growth-friendly treatment and intended as a definitive treatment).Between july 2007 to june 2017, a total of 1298 patients (717 male and 581 female) with a mean age of 6.7±2.8 years were included in the study.Surgery was performed using a vertical expandable prosthetic titanium ribs (veptr) in 390 patients and competitor devices in 1688 patients.The mean follow-up period was unknown.The following complications were reported as follows: 104 patients underwent final fusion, out of 119 patients in veptr group who had completed treatment from 2007 to 2018.This report is for an unknown synthes veptr constructs.This report is for (1) unk - constructs: veptr.This is report 1 of 1 (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 ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 11348074
• MDR Text Key: 232531152
• Report Number: 2939274-2021-00954
• 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: Physician
• Type of Report: Initial
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• 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: 01/28/2021
• 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