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 Pain (1994); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).510 k: 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: swarup, i.Et al.(2020), impact of growth friendly interventions on spine and pulmonary outcomes of patients with spinal muscular atrophy, european spine journal, vol.Xx, pages 1-7 (usa).The aim of this study is to assess the effect of growth friendly constructs and chest wall support (cws) on spinal deformity correction and pulmonary function in patients with spinal muscular atrophy (sma).A total of 66 patients with a diagnosis of smz were treated with growth friendly constructs.Theam mean age of the patient was 7.3 years with a range of 1.9-12.8 years.17 patients were treated with an mcgr and 47 patients were treated with a veptr.Mcgrs were used starting in 2013, and since that time,17 patients were treated with an mgcr and 11 patients were treated with a veptr.All patients were followed-up with a minimum of 2 years.The following complications were reported: 44.7 percent of patients had complications.47 percent had implant failure/migration.29.8 percent had surgical site infection/deep infection.8.5 percent had pain.10.6 had other complications.This report is for an unknown synthes veptr.This report is for (1) unk - constructs: veptr.This is report 1 of 2 (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: 11344226
• MDR Text Key: 241072815
• Report Number: 2939274-2021-00944
• 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: 02/18/2021
• 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