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

Device Problem Mechanical Problem (1384)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article.Complications in pediatric spine surgery using the vertical expandable prosthetic titanium rib; grégory lucas , md, gérard bollini , md, jean-luc jouve , md , jérome sales de gauzy , md , franck accadbled , md , pierre lascombes , md , pierre journeau , md , claude karger , md , jean françois mallet , md , petre neagoe , md , jérome cottalorda , md , benoit de billy , md , jean langlais , md , bernard herbaux , md , damien fron , md , and philippe violas , md.Lippincott williams & wilkins spine volume 38, number 25 (2011), pp e1589¿e1599.This is multicenter retrospective study to describe the complication rate of the french vertical expandable prosthetic titanium rib (veptr) series involving patients treated between august 2005 and january 2012.Of the 58 case fi les, 54 were available for analysis.The series involved 33 girls and 21 boys with a mean age of 7 years (range, 20 months¿14 years and 2 months) at primary veptr surgery.During the follow-up period, several complications occurred.Mean follow-up was 22.5 months (range, 6¿64 mo).In total, 184 procedures were performed, including 56 veptr implantations, 98 expansions, and 30 nonscheduled procedures for different types of complications: mechanical complications (i.E.Fracture, device migration), device-related and infectious complications, neurological disorders, spine statics disturbances.Altogether, there were 74 complications in 54 patients: a complication rate of 137% per patient and 40% per surgery.Comparison of the complications in this series with those reported in the literature led the authors to suggest solutions that should help decrease their incidence.This report is for unknown veptr construct.This is report 1 of 7 for complaint (b)(4), for bone fracture due to veptr (11 patients).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Date of event: complications in pediatric spine surgery using the vertical expandable prosthetic titanium rib.Lippincott williams & wilkins spine volume 38, number 25 (2011), pp e1589¿e1599.Additional device info: this report is for unknown veptr construct.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: COMMON NAME 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: 3776325
• MDR Text Key: 4436675
• Report Number: 2520274-2014-11053
• 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: Foreign,Literature,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 04/28/2014
• 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