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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).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.Based on the information available, it has been determined that no corrective and 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: li, y.Et al.(2020), elevated serum titanium levels in children with early onset scoliosis treated with growth-friendly instrumentation, journal of pediatric orthopedics, vol.40, number 6, pages e420-e423 (usa).The purpose of this study was to compare serum titanium levels in early onset scoliosis (eos) patients treated with tgr, mcgr, and veptr.A total of 23 patients were treated with traditional growing rods (tgr), magnetically controlled growing rods (mcgr) and a veptr.2 patients were treated with tgr, 8 patients were treated with mcgr while 13 patients were treated with a veptr.Implant used were expedium (depuy synthes, raynham, ma; legacy; medtronic, minneapolis, mn) for tgr, magec (nuvasive, san diego, ca) for mcgr, and veptr depuy synthes.The article did not specify which of the devices were being used to capture the following complications: binary comparisons showed that the veptr patients had a significantly higher serum titanium level than the tgr patients.This report is for an unknown synthes veptr.This report is for (1) unk - constructs: veptr.This is report 1 of 1 (b)(4).Related product complaint: (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: 11345793
• MDR Text Key: 232520719
• Report Number: 2939274-2021-00951
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/18/2021
• 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