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 Problems Failure of Implant (1924); Post Operative Wound Infection (2446)

Event Date 12/30/2019

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown 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.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.

Event Description

This report is being filed after the review of the following journal article: baky f., et al (2019)the effect of expansion thoracostomy on spine growth in patients with spinal deformity and fused ribs treated with rib-based growing constructs, spine deformity volume 7, pages 836-841 (usa) https://doi.Org/10.1016/j.Jspd.2019.01.004 this retrospective study aims to quantify the effect of expansion thoracostomy at the time of rib-based growing device implantation on spinal height and cobb angle correction in early-onset scoliosis patients with fused ribs.Between 1999 and 2014, patients with early-onset scoliosis and associated rib fusions (diagnosed before age 10 years) were identified across the member institutions of two multicenter eos patient registries.A total of 151 patients (80 female and 71 male) with a mean age of 4.7 years (range: 2 monthse16.5 years) at index surgery met the inclusion criteria.A total of 103 patients (50 females,53 males) age 4.54 years underwent expansion thoracostomy at the time of implantation, whereas 48 (30 females, 18 males) age 5.08 years were treated with rib-based expansion device alone each patient was treated with a rib-based expandable construct (veptr; synthes, west chester, pa) with or without simultaneous expansion thoracostomy.The minimum follow-up was two-year (mean 6.6 years).The following complications were reported as follows: of the thoracostomy group: 24 surgical site infections, 25 implant failures, 41 unplanned returns to the operating room, no.Of revision surgeries: 2.3.For unique patients in the thoracostomy group: 11 surgical site infections, 9 implant failures, 14 unplanned returns to the operating room.Of the group treated without thoracostomy: 12 surgical site infections, 6 implant failures, 27 unplanned returns to the operating room, no.Of revision surgeries: 2.Of unique patients in the no thoracostomy group: 11 surgical site infections, 4 implant failures, 12 unplanned returns to the operating room.Only 19% of patient underwent final fusion, underwent final fusion: 19/103 (thoracostomy group) , 10/48 (no thoracostomy).21 device migrations (thoracostomy group), 14 device migrations (group treated without thoracostomy), 6 device migrations (for unique patients in the thoracostomy group), 5 device migrations (of unique patients in the no thoracostomy group).This report is for an unknown synthes rib-based expandable construct (veptr).A copy of the literature article is being submitted with this medwatch.This report is for one (1) unk - constructs: veptr.This is report 1 of 2 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11330001
• MDR Text Key: 239454868
• Report Number: 2939274-2021-00859
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• 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: 01/27/2021
• 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