MAUDE Adverse Event Report: SYNTHES; PROSTHESIS, RIB REPLACEMENT

Catalog Number UNK - VEPTR

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Date 10/13/2010

Event Type  Injury  

Manufacturer Narrative

The device was used for treatment, not diagnosis.Mean age 48.6 months; range 15-168 months.8 males, 8 females.Weight not reported.This report is for unknown veptr, unknown part number and unknown lot number.Flynn, j., et al.(2010).Is the vertebral expandable prosthetic titanium rib a surgical alternative in patients with spina bifida? clin orthop relat res (2011) 469:1291¿1296 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: is the vertebral expandable prosthetic titanium rib a surgical alternative in patients with spina bifida? twenty nonambulatory patients with myelodysplasia were part of a multicenter investigational device exemption study of 214 patients treated with the vertebral expandable prosthetic titanium rib (veptr) system.Sixteen (16) of the 20 patients were analyzed.The average age at first surgery was 48.6 months.Eight (8) patients were male and eight female.The mean age at the initial procedure was 48.6 months (range 15¿168 months).The minimum follow-up was 25 months (mean, 59 months; range, 25¿164 months).Complications directly related to veptr included 12 events.There were five soft tissue superficial wound infections that were treated with nutritional support, local debridement and antibiotics; two deep wound infections requiring removal of the implant; and five implant migrations: two superior migrations of the rib cradle, one superior migration of the rib cradle with a brachial plexus palsy, one migration of the dunn-mccarthy hook, and one fracture of the dunn-mccarthy rod.It was the opinion of the authors that veptr is a reasonable treatment option for spinal deformity in the immature, nonambulatory myelodysplasia population correcting spinal the deformity, allowing spinal growth, and maintaining adequate respiratory function.The rate of complications were within the range reported for spinal fusion using standard approaches.This report is for 7 infections and 3 implant migrations for (b)(4).

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES; 1302 wrights lane east; west chester; PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3776204
• MDR Text Key: 21152697
• Report Number: 2520274-2014-11060
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/03/2014

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?: Yes
• Device Operator: Other
• Device Catalogue Number: UNK - VEPTR
• 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