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

Device Problem Loose or Intermittent Connection (1371)

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 literature article; this report is being filed after the subsequent review of the following literature article; zuiani; use of vertical expandable prosthetic titanium rib for the treatment of congenital kyphosis in patients with thoracic myelomeningocele.¿ brazil; this article reports complications that were reported in studies to evaluate clinical and radiographic postoperative results of congenital kyphosis correction in thoracic meningomyelocele pacientes vertical expandable prosthetic of using titanium for the rib (veptr).A retrospective study of 19 thoracic meningomyelocele and congenital kyphosis patients that were subjected to the veptr treatment between october 2005 and october 2008, with radiographic evaluation and immediate post and pre-operative clinical practice.Also, the duration of surgical procedure, the need for blood transfusion and postoperative complications were assessed.Technique related complications: complications related to the procedure after system installation.Specific complications were i infections with loosing of the implant on 1 patient.This report if for 2 of 2 for (b)(4).This report is for an unknown veptr, unknown quantity part and lot number.

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).This report is for unknown veptr implant, unknown quantity, unknown item number, unknown lot number.(b)(4).The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot and 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: 4584253
• MDR Text Key: 17697096
• Report Number: 2520274-2015-11585
• 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: Foreign,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: 03/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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