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

Catalog Number UNK - VEPTR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Respiratory Distress (2045); Tissue Damage (2104)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article ¿abstracts of the meeting of the french society.¿ the specific abstract title is ¿vetpr for thoracic insufficiency syndrome: report on a series of 19 cases.¿ between june 2008 and september 2011, 23 veptr (vertical expandable prosthetic titanium rib) were implanted in 19 patients.There were 8 boys and 11 girls.The mean age was 7.1 years and the range was 1.5 to 12 years.A retrospectively study was done on all the clinical and radiological notes of the patients.Fifty-two percent of these patients experienced complications.Four implants caused cutaneous complications, for which further surgery was required; 4 implants caused a rib fracture requiring surgical repair; 4 implants caused infection-type complications; and one caused a respiratory complication.It was the conclusion of the author that the veptr system is effective for the surgical treatment of thoracic insufficiency syndrome with a high incidence of complications.No additional information was provided.This report 1 of 5 for (b)(4).This report is for the unknown veptr.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Mean age 7.1 years, age range 1.5 to 12 years.Female 11, males 8.Specific date of article published is unknown, published year is 2012.This report is for 13 unknown veptr.Implant/explant date: unknown.Bollin et al (2012).Veptr for thoracic insuffiecieny syndrome: report on a series of 19 cases.Eur spine j, 21: 1430.Without a lot number the device history records review could not be competed.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 Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3765491
• MDR Text Key: 4467201
• Report Number: 2520274-2014-10996
• 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: 04/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - VEPTR
• Was Device Available for Evaluation?: No
• 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: 7 YR