MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNKNOWN VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) IMPLANT; PROSTHESIS, RIB REPLACEMENT

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

Patient Problems Respiratory Distress (2045); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown vertical expandable prosthetic titanium rib (veptr)/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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: nossove, s.Et al.(2015), are we reducing respiratory assistance requirements at two years?, abstracts/spine deformity vol.3, pages 628-629 (usa).The aim of this study was to identify patients with early onset scoliosis (eos) and abnormal initial assisted ventilation rating (avr) who underwent early rib-based vertical expandable prosthetic titanium rib (veptr) treatment to determine effect on avr respiratory status.A total of 79 patients who were treated with an unknown synthes vertical expandable prosthetic titanium rib veptr under the age of 10 years old at initial implant with minimum of 2 years follow-up date.Statistical analysis was performed on groups which had stable, declined, and improved avr at final follow-up.The following complications were reported as follows: 9 patients deteriorated and 50 patients remained at the same level.Initial average cobb angle in those with no change (63.5 degrees) was less than in those with deterioration (85.5 degrees).This is for an unknown synthes vertical expandable prosthetic titanium rib (veptr).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in 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.

• Brand Name: UNKNOWN VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) IMPLANT
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8714405
• MDR Text Key: 148527179
• Report Number: 2939274-2019-58757
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/19/2019
• Supplement Dates Manufacturer Received: 06/21/2019
• Supplement Dates FDA Received: 06/21/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention