MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - VEPTR IMPLANTS; 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 vertical expandable prosthetic titanium rib (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: ramirez, n.Et al (2009), the vertical expandable prosthetic titanium rib in the treatment of spinal deformity due to progressive early onset scoliosis, journal of pediatric orthopaedics b.2009, volume 18 number 4, pages 197-203 (usa) doi:10.1097/bpb.0b013e32832bf5e0.This retrospective study aims to show how efficient and safe the vertical expandable prosthetic titanium rib (veptr) technique in the treatment of early onset scoliosis.From 2005 to 2008, a total of 17 patients ( 8 male and 9 female) with early onset scoliosis and with an average age of 6.5 years (range 2.2¿10.5 years) at the time of primary veptr implantation were included in the study.Vertical expandable prosthetic titanium rib (veptr; synthes spine co., west chester, pennsylvania, usa) was used.The mean follow-up time after veptr implantation was 25 months (range 12¿38 months).The following complications were reported as follows: 1 patient whose age at the time of surgery was (b)(6) year old had migration of the sacral hook of the rib¿pelvis construct.1 patient whose age at the time of surgery was (b)(6) year old had migration of the sacral hook of the rib¿pelvis construct.1 patient whose age at the time of surgery was (b)(6) had migration of the sacral hook of the rib¿pelvis construct.1 patient whose age at the time of surgery was (b)(6) year old had migration of the sacral hook of the rib¿pelvis construct.1 patient whose age at the time of surgery was (b)(6) year old had rib fracture at the superior cradle, which was reimplanted at a lower level at the time of scheduled lengthening.1 patient, female and whose age at the time of surgery was (b)(6) year old had device-related infection and removal of the device.There was a mild increase in the thoracic kyphosis.This is report 3 of 7 for (b)(4).This report is for an unknown synthes vertical expandable prosthetic titanium rib (veptr).

• Brand Name: UNK - VEPTR IMPLANTS
• 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: 8781745
• MDR Text Key: 150748673
• Report Number: 2939274-2019-59133
• 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: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• 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
• Date Manufacturer Received: 06/17/2019
• 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
• Patient Age: 9 YR