MAUDE Adverse Event Report: SYNTHES (USA); PROSTHESIS, RIB REPLACEMENT

Catalog Number UNK - VEPTR

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

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

This report is being filled after the subsequent review of the following journal article "halo-gravity traction versus surgical release before implantation of expandable spinal devices".An observational study of 124 patients with severe early-onset spinal deformity were treated with the vertical expandable prosthetic titanium rib or growing rods.Of the 124 patients, 96 patients had all the radiographic data required for the study.Before implantation of the device, 12 underwent halo-gravity traction (hgt) and 13 had a spinal release (sr).This study is based on x-rays obtained before and after surgery and at the last follow-up and on medical records.The thoracic scoliosis and kyphosis, and the thoracic height and spinal length was measured on the x-rays.Post-operative complications were also collected.Thirteen veptr participants had 23 rib fractures.This is 2 of 3 report for (b)(4).Report for 13 unknown veptr.

Manufacturer Narrative

Mean age 5.77 years.This mean age for 96 patients that had all x-rays required for the study.Total 96 patients- 49 female & 47 male.Article published; april 2011.Exact date unknown.This report for 13 unknown veptr, unknown part#/lot#.Jean-francois et al (2011, april).Halo-gravity traction versus surgical release before implantation of expandable spinal devices.A comparison of results and complications in early-onset spinal deformity.J.Spinal disorder tech, volume 24, number 2, 99-104.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3768171
• MDR Text Key: 4374066
• Report Number: 2520274-2014-11002
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PH030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - VEPTR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2014
• 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: 6 YR