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

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

Patient Problems Erosion (1750); No Code Available (3191)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article: motoyama, e.K., yang, y.I., and deeney, v.F.(2009).Thoracic malformation with early-onset scoliosis: effect of serial veptr expansion thoracoplasty on lung growth and function in children.Paediatric respiratory reviews 10, p12-17.This was retrospective review of study performed prior to 2009.There was a preliminary report which included 10 patients aged 2-10 years old and a follow up study which was performed prior to november 2007 and included 24 children.The preliminary study with 10 children included the age range 1.8-9.8 years with a median of 4.3yrs.Co-morbidities for these patients included: jarcho-livine syndrome (n=1) and congenital heart disease (n=2).The time span between the first and last pulmonary function test was 7-33 months (median 23 months).Preliminary results, complications: specific compliance was abnormally decreased in some patients indicating abnormally stiff chest walls.Complications were infrequent and without major morbidity and there was no mortality.The follow-up study population included: 24 patients (15 girls and 9 boys), age at start of surgery was 4.6 years (range 1.8-10.8yrs).These patients had serial veptr thoracoplasties (2-12 times).Six of them had veptr inserted in both hemithoraces.The time interval between the first and last tests varied between 12mths and 5.6 years (median 2.7 yrs).All had the initial diagnosis of thoracic insufficiency syndrome with early onset scoliosis (congenital, neuromuscular and infantile with failed previous treatment) together with fused ribs, congenital heart disease, vater association, tracheoesophageal fisula, tethered spinal cord, jarcho-levine syndrome, noonan syndrome, conradi-huenermann chondrodyplasia, williams syndrome, goldenhar syndrome and myelomeningocele or their combinations.Four had partial spinal fusions prior to veptr insertion.The follow up study complications: specific compliance was abnormally decreased in some patients indicating abnormally stiff chest walls, severe restrictive defect (n=8) and specific compliance decreased further in most patients, and one skin erosion which resolved without sequelae.This report is for an unknown veptr with unknown part and lot number and unknown quantity.A copy of the literature article (or abstract) is being submitted with this medwatch.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).This report is for an unknown quantity of veptr with unknown part and lot number.(b)(6).Specific compliance was abnormally decreased in some patients indicating abnormally stiff chest walls, severe restrictive defect (n=8) and specific compliance decreased further in most patients.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.

• 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: 4593556
• MDR Text Key: 18932706
• Report Number: 2520274-2015-11754
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PH030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2015
• 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: 02/15/2015
• 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