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

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

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

This report is being filed after subsequent review of the following article: samdani (april 2009): bilateral use of the vertical expandable prosthetic titanium rib attached to the pelvis: a novel treatment for scoliosis in the growing spine.J.Neurosurg spine, vol 10, 287-292.Usa in this article the authors report their experience with using bilateral veptrs from the ribs to the pelvis for children with severe, early onset scoliosis.Eleven children (7 female, 4 male, avg age: 71 months) were identified who had been treated with bilateral veptrs from the ribs to the pelvis.The authors conducted a retrospective review and collected the following data: clinical diagnosis, age at surgery, number of lengthening procedures, and complications.In addition, pre- and postoperative radiographs were reviewed to measure maximum cobb angle (both thoracic and lumbar), thoracic height, total spine height as measured from t-1 to s-1, thoracic kyphosis (t2¿12), and lumbar lordosis (l1¿s1).There were no neurological, vascular, or visceral complications in these patients.Four of the 11 patients experienced a total of 6 other complications.This report refers to one patient with arthrogryposis underwent veptr placement at the age of (b)(6) years and (b)(6).Subsequently, her o2 requirement decreased and her tracheostomy tube was removed, but she developed an infection caused by (b()6) that required hardware removal.The patient was then awaiting reinsertion of her veptr devices.This is report 3 of 3 for (b)(4).This report is for an unknownveptr, 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.Samdani (april 2009): bilateral use of the vertical expandable prosthetic titanium rib attached to the pelvis: a novel treatment for scoliosis in the growing spine.J.Neurosurg spine, vol 10, 287-292.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.

• 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: 4568304
• MDR Text Key: 15897540
• Report Number: 2520274-2015-11401
• 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: 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: 03/04/2015
• 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: 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
• Patient Age: 2 YR