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

Device Problems Break (1069); Migration or Expulsion of Device (1395); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

23rd congress of the european society for pediatric neurosurgery (espn), amsterdam-the netherlands, 1¿5 may 2012.Op-70; philip kunkel, ralf stuecker (hamburg, germany).Childs nerv syst (2012) 28:775¿776.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.

Event Description

This report is being filed after the subsequent review of the following journal article.23rd congress of the european society for pediatric neurosurgery (espn), amsterdam-the netherlands, 1¿5 may 2012.Op-70; philip kunkel, ralf stuecker (hamburg, germany).Childs nerv syst (2012) 28:775¿776.The literature article is attached to this medwatch.This case was presented in the congress of european society of pediatric neurosurgery.In a 5 years period six children with spina bifida and gibbus deformity were treated by implantation of bilateral vertical expandable prosthetic titanium rib (veptr) clamped between the upper ribs and the posterior iliac crest.Mean age at implantation surgery was 6.6 years (range: 4.8- 9.5 years).Mean follow-up period was 27.6 months (range: 14¿ 61 months).A mean number of 4.5 surgeries per child were carried out (total number: 27).In one case a veptr implant had to be temporarily removed because of deep wound infection.In 25% of all scheduled lengthening procedures, implant revisions (migrated, broken or undersized implants) had to be complemented.Mean distracted length of the devices was 2.9 cm (range: 2¿6 cm).In one boy veptr treatment lasted for 5 years.At the age of 14.5 years, after growth completion was achieved, he received a limited kyphectomy and posterior spinal fusion.This report is for unknown veptr construct.This is report 2 of 2 for complaint (b)(4) for implant revisions due to migration, broken or undersized implants.

• 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: 3776244
• MDR Text Key: 21152698
• Report Number: 2520274-2014-11048
• 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: Other Health Care 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?: No
• 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