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

Catalog Number UNK - VEPTR

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article "vertical expandable prosthetic titanium rib device insertion: does it improve pulmonary function".A total of 26 patients underwent 86 procedures (29 vertical expandable prosthetic titanium rib insertions and 57 expansions) between october 2006 and march 2010.The patients had an average age of 91 months.Outcome measures included pulmonary function tests (pft) and every 6 months in all patients who were not ventilator-dependent and can cooperate with the procedure, lung volumes in patients who consented to 3-dimensional reconstruction of thoracic computed tomography scans preoperatively and yearly, a modified scoliosis research society- 22 (srs-22) questionnaire, and scoliosis angles were measured preoperatively and at each post-operative visit in all patients, with 23 of 26 patients having adequate follow-up for analysis of these values.In all, 36 complications occured, reoperations were required in 3 to reposition the hardware due to dislodgement.This report 1 of 1 for (b)(4).This report is for unknown veptr.

Manufacturer Narrative

Mean age 90.7 +/- 41 months.Mean age for 26 patients.Total 26 patients- 10 female & 16 male.Article published; 2011.Exact date unknown.This report for 3 unknown veptr, unknown part#/lot#.Implant date: unknown.Samir et al (2011).Vertical expandable prosthetic titanium rib device insertion: does it improve pulmonary function?.Journal of pediatric surgery, volume 46, 77-80.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: 3768144
• MDR Text Key: 4362667
• Report Number: 2520274-2014-11005
• 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

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 04/23/2014
• 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