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

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following literature article: campbell, r.M., et al (2007).The effect of mid-thoracic veptr opening wedge thoracostomy on cervical tilt associated with congenital thoracic scoliosis in patients with thoracic insufficiency syndrome.Spine, volume 32, number 20, pp 2171-2177.Usa article.The purpose of the study was to report the efficacy and safety of veptr mi-thoracic opening wedge thoracostomy in treatment of cervical tilt and head/truncal decompensation in children with thoracic insufficiency syndrome associated with thoracic congenital scoliosis.The study included: 14 patients (6 females, 8 males), mean age at time of surgery 4.4 years (ranging 1.8-12.5 years), mean follow-up time was 3.4 years (ranging 2-5.75 years), and the patients had the following co-morbidities: congenital renal abnormalities, congenital heart disease, asthma, and spinal cord abnormalities.Two patients had spinal fusions before veptr treatment.Four patients had tether release before veptr.Most patients had a unilateral hybrid rib-to spine veptr and rib-to rib veptr; 3 patients had bilateral veptr construct.Multiple radiographs were taken pre-operatively and post-operatively as well as ct scans and mris.One (n=1) had the hybrid veptr extending to the iliac crest experienced 2 s-hook fractures which were replaced.This report is for an unknown veptr with unknown part and lot numbers and quantity.This is report 5 of 5 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Literature citation: campbell, r.M., et al (2007).The effect of mid-thoracic veptr opening wedge thoracostomy on cervical tilt associated with congenital thoracic scoliosis in patients with thoracic insufficiency syndrome.Spine, volume 32, number 20, pp 2171-2177.This report is for an unknown veptr with unknown part and lot numbers.(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

Device was used for treatment, not diagnosis.(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: 4592268
• MDR Text Key: 5452078
• Report Number: 2520274-2015-11734
• 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: 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

• 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
• Initial Date Manufacturer Received: 04/13/2015
• Initial Date FDA Received: 03/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA 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