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

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 literature abstract: balioglu: growing rods and non-fusion treatment for early onset scoliosis (abstracts from the 3rd international congress on early onset scoliosis and growing spine, 20¿21 november 2009, istanbul, turkey), pg 525.This abstract refers to posterior instrumentation and distraction that were applied to 6 patients between 2007 and 2009 (2 juvenile, 4 congenital) with early onset scoliosis (eos) (5 female, 1 male, mean age 7.3; 3.5¿11).A single rod was applied in 1 patient, double rods in 4 patients, veptr in 1 patient.Distraction period was an average of 6 months.Follow-up period was an average of 15.6 (4¿29) months.The average correction was 42% (12¿77) at the final check.Neurological deficit did not develop.This report refers to one patient whose implant loosened but was reinserted.(b)(4).This report is for an unknown veptr, unknown part#/lot#.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Balioglu: growing rods and non-fusion treatment for early onset scoliosis (abstracts from the 3rd international congress on early onset scoliosis and growing spine, 20¿21 november 2009, istanbul, turkey), pg 525.This report is for unknown veptr/unknown quantity/unknown lot.(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: 4605496
• MDR Text Key: 21769881
• Report Number: 2520274-2015-11421
• 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: Foreign,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: 03/16/2015
• 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
• 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