MAUDE Adverse Event Report: SYNTHES USA; APPLIANCE,FIXATION,SPINAL, INTERVERTEBRAL BODY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Murphy, r., moisan, a., kelly, d., warner, w., jones, t., and sawyer, j.(2016) use of vertical expandable prosthetic titanium rib (veptr) in the treatment of congenital scoliosis without fused ribs.This report is for unknown ¿ vertical expandable prosthetic titanium rib (veptr)/unknown quantity/unknown lot.(other number) udi: unknown part number, udi is unavailable.(b)(4).The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.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 subsequent review of the following literature article murphy, r., moisan, a., kelly, d., warner, w., jones, t., and sawyer, j.(2016) use of vertical expandable prosthetic titanium rib (veptr) in the treatment of congenital scoliosis without fused ribs.J pediatr orthop, volume 36: 329-335.The purpose of this article is to review the outcomes of vertical expandable prosthetic titanium rib (veptr) treatment of congenital scoliosis (cs) in patients without fused ribs in terms of coronal and sagittal correction, maintenance of spine growth, and complications.This study started with twenty-five (25) patients of which were thirty (13) females and twelve (12) males.The average age at implantation +/- sd was 5.7 years +/- 3.3 years (range, 10 months to 12.3 years).The average follow-up was 4.5 +/- 2.6 years (range, 0.5 to 10.9 years).This is report 1 of 2 for (b)(4).This report is for an unknown - vertical expandable prosthetic titanium rib (veptr) and refers to fifteen (15) of the 25 patients had a total of 41 complications in which 20% had infection and 7% had neurogenic pain, one (1) unknown patient had perioperative paraplegia, one (1) unknown patient had grade iii complications of refusal of the ribs to expand after thoracotomy which altered planned course of treatment, and one (1) unknown patient had grade iii complications of rib fracture which altered planned course of treatment.

• Type of Device: APPLIANCE,FIXATION,SPINAL, INTERVERTEBRAL BODY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5960806
• MDR Text Key: 55075317
• Report Number: 2520274-2016-14579
• Device Sequence Number: 1
• Product Code: KWQ
• 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,litera
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• 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: 07/27/2016
• 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