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

Device Problem Insufficient Information (3190)

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

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article ¿the efficacy of rib-based distraction with veptr in the treatment of early-onset scoliosis in patients with arthrogryposis¿.Data for the study was provided by six different pediatric health centers and included diagnostic imaging and medical records from their patients.The study included 10 children with arthrogryposis multiplex congenital (amc) and early-onset scoliosis who were treated with the vertical expandable prosthetic titanium rib (veptr) device from 2004 to 2011.Seven patients were female and 3 were male.The mean age at the time of the initial veptr insertion was 4.8 years.Six complications occurred in 4 of the 10 patients.The 6 complications occurred over the course of 62 procedures.Three patients were noted to have an infection (site unspecified).The patients required an average of 6.2 additional procedures and repetitive surgical intervention, however, compromised tissues may have increased the infection risk.An implant failure was noted and rod removal was required in 1 patient in whom the veptr device was reinserted after a period in the halo gravity traction and a course of antibiotics.Two patients experienced rib anchor failure due to the small diameter and more fragile ribs in this young population also is a recognized complication of this technique.This is report 2 of 3 for (b)(4), for 1 unknown veptr construct, which involves 1 patient (referred to as patient (b)(6)) with implant failure due to uncontrolled infection who required rod removal and reinsertion of the veptr device after a period in halo gravity traction and a course of antibiotics.

Manufacturer Narrative

Device was used for treatment, not diagnosis.The study included 10 children; 7 were female and 3 were male.The mean age at the time of initial veptr insertion was 4.8 years (range, 0.9-9.3y).Pediatric orthopaedics, volume 34, number 1, january 2014.Standard posteroanterior and lateral spine radiographs, taken upright when possible.Images were obtained before veptr insertion, at 6 weeks after insertion, and at final follow-up.All children in the study had arthrogryposis multiplex congenital (amc) and early-onset scoliosis.Eight patients had amyoplasia, 1 had escobar syndrome, 1 had freeman-sheldon syndrome.Four children were nonambulators, 3 were household ambulators, and 3 were community ambulators.This report is for 1 unknown veptr construct.The article classifies this event as an implant failure, but does not specify why; rod removal was required in the patient whom the vetpr device was reinserted after a period in halo gravity traction and a course of antibiotics.Astur, n.Et al.(2014, january).¿the efficacy of rib-based distraction with veptr in the treatment of early-onset scoliosis in patients with arthrogryposis¿.Pediatric orthopaedics, volume 34, p 8-13.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 (Section G): SYNTHES (USA)
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3761891
• MDR Text Key: 4415851
• Report Number: 2520274-2014-10726
• 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: 04/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 2 YR