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: scoliosis review - the northern ireland experience with growth rods.Spence, d.Et al.(2013) scoliosis review - the northern ireland experience with growth rods.Eur spine j (2013) 22 (suppl 1): s54-s78.This was a retrospective study of 25 patients (17 male, 8 female, with an average age at time of surgery 6.6 years, and range 2-12 years) with scoliosis.From june 2004 to october 2012, the patients had growth rods inserted and subsequently lengthened.Nine of the patients started with a single rod and required conversion to dual rods at some point.Fourteen patients had dual rods inserted initially; one remaining patient underwent vertical expandable prosthetic expandable rib (veptr) implantation.The levels of implantation varied from t2-l5 with hooks and screws used superiorly.The cobb angle was measured preoperatively and postoperatively.X-rays were reviewed (dates and results not specified), and cobb angles recorded.The results showed that the rods can dramatically improve scoliosis deformity and the improvement is maintained with consequent lengthening procedures.Complications in this study included 1 broken rod and 1 rod that "cut out" which required revision surgery.This is report 2 of 2 for (b)(4).This report is for an unknown rod.A copy of the literature abstract is being submitted with this medwatch.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Spence, d.Et al.(2013) scoliosis review - the northern ireland experience with growth rods.Eur spine j (2013) 22 (suppl 1): s54-s78.This report is for 1 unknown rod, unknown lot.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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.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: 4199875
• MDR Text Key: 15912174
• Report Number: 2520274-2014-14109
• 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: Foreign,Literature,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2014
• Initial Date FDA Received: 10/24/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/03/2014; 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention