MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: VEPTR; PROSTHESIS, RIB REPLACEMENT

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown 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.(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: larson, a.N.Et al (2019), spine deformity with fused ribs treated with proximal rib- versus spine-based growing constructs, spine deformity, vol.7 (1), pages 152-157 (usa).The aim of this retrospective with prospective study is to compare the outcomes achieved in children with early-onset scoliosis with associated rib deformity treated with proximal rib- versus spine-based growing constructs.Between 1999 to 2014, a total of 169 patients (92 females and 77 males) with a mean age of 4.7 years, were included in the study.Only 153 patients were treated with rib-based devices - vertical expandable prosthetic titanium rib (veptr).While the remaining group with proximal spine-based anchors.The mean follow-up between the two groups was 6.6 years in the rib-based group and 5.9 years in the spine-based group.The following complications were reported as follows: 30 patients had an infection.30 patients had implant failures.31 patients had unplanned returns to the operating room.Kyphosis increased in the rib-based group over the study period.There was a higher revision rate in the rib-based cohort which was 2.3.41 patients had device migrations.This is report 2 of 2 for (b)(4).This report is for an unknown synthes veptr.

• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8878397
• MDR Text Key: 153804932
• Report Number: 2939274-2019-59626
• 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: 07/12/2019

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 08/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention