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

Catalog Number UNK - VEPTR

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This report is being filed after the subsequent review of the following journal article: " scoliosis research society 47th annual meeting and course final program." abstract# (b)(4): ajeya joshi and et al: management of thoracic insufficiency syndrome (tis) in congenital scoliosis patients using vertical expandable prosthetic titanium rib (veptr) a review of 32 cases of progressive congenital scoliosis (pcs) with thoracic insufficiency syndrome (tis) treated with vertical expandable prosthetic titanium rib.Patients averaged 4.1 +/- 3.1 years at first vertical expandable prosthetic titanium rib implant, with average follow-up of 3.8 +/- 1.2 years.Charts were reviewed for operative course, assisted ventilation rate (avr) changes, and complications.Sitting radiographs were measured for cobb angle, sagittal profile, thoracic height and width, and space available for lungs (sal).Opening wedge thoracostomy (owt) usually accompanied initial device implantation and was repeated later in a subset of patients.Device dislodgements occured in 16 patients and infections occured in 6 patients.This is report 3 of 4 for (b)(4).This report is for unknown veptr, implanted in 16 patients.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Date the abstract was published is unknown.This report is for unknown veptr, unknown part/unknown lot.This report for 16 unknown veptr.Joshi et al, management of thoracic insufficiency syndrome (tis) in congenital scoliosis patients using vertical expandable prosthetic titanium rib (veptr), pg# 78 abstract# 41, scoliosis research society, 47th annual meeting & course, sep 5-8, 2012.Without a lot number the device history records review could not be completed.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: 3765543
• MDR Text Key: 4467207
• Report Number: 2520274-2014-10992
• 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?: No
• Is this a Product Problem Report?: Yes
• 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