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

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

Patient Problems Unspecified Infection (1930); Tissue Damage (2104)

Event Type  Injury  

Event Description

This report is being filed after subsequent review of the following abstract: abstract 13: simmons iii: topical negative pressure therapy for wound complications following veptr surgery.Abstracts from the 3rd international congress on early onset scoliosis and growing spine(20¿21 november 2009, istanbul, turkey) pg 508.A retrospective review was performed identifying thoracic insufficiency syndrome (tis) patients in the author's institution database whose vertical expandable prosthetic titanium rib (veptr) treatment was complicated by deep infection or wound dehiscence with subsequent management with topical negative therapy (tnp) therapy.Data collected through inpatient and outpatient chart review included presentation of infection, other surgical treatments besides tnp, microbial profile, and eventual outcome of infection and wound status.Radiographic analysis was performed as well.Fourteen patients received a total of 19 tnp applications.Recurrent wound infection occurred in 5 of the patients.Mean age at the time of tnp therapy was 69 months (range 12¿104 months).All wounds healed, 11 by secondary intention, 6 by delayed primary closure, and 2 by a combination of closure methods.Implant retention was possible in 7 out of 19 cases.When veptr removal was needed, average interval to reimplantation was 7 months (range 6¿11 months), but 5 patients could not be reimplanted due to soft tissue deficiencies in spite of infection resolution.Veptr removal was associated with variable loss of deformity correction.Patients were tolerant of tnp therapy.This report refers to adverse events: post-operative infection, wound dehiscence and revision related to infection.This is report 1 of 1 for (b)(4).This report is for an unknown veptr, unknown part#/lot# and unknown quantity.A copy of the literature abstract is being submitted with this medwatch.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Abstract 13: simmons iii: topical negative pressure therapy for wound complications following veptr surgery.Abstracts from the 3rd international congress on early onset scoliosis and growing spine(20¿21 november 2009, istanbul, turkey) pg 508.This report is for unknown veptr/unknown quantity/unknown lot.Initial reporter phone number: (b)(6).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.

Manufacturer Narrative

(b)(4).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: 4598876
• MDR Text Key: 5627452
• Report Number: 2520274-2015-11420
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2015
• 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