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 Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: garg, s.Et al (2016), variability of surgical site infection with veptr at eight centers: a retrospective cohort analysis, spine deformity, vol.4 (1), pages 59-64 (usa).The aim of this retrospective study from a multicenter prospectively collected database was to describe clinical characteristics and infection rates in modern vertical expandable prosthetic titanium rib (veptr) surgery.Between 2007 to 2013, a total of 213 patients implanted with veptr at eight centers were included in the study.The average follow-up was 4.1 years (range 1.7-6.3).The following complications were reported as follows: 38 patients developed infection requiring operative debridement.20 of these patients underwent either partial or complete implant removal to resolve infection; however, only 3/38 resulted in abandonment of veptr treatment.This report is for an unknown synthes veptr constructs.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional 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.

• 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: 13003902
• MDR Text Key: 286860852
• Report Number: 2939274-2021-07076
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• 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: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention