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

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 08/06/2014

Event Type  Injury  

Event Description

This report is being filed after subsequent review of the following abstract: ozgur dede and et al (2014): pulmonary and radiographic outcomes of veptr (vertical expandable prosthetic titanium rib) treatment in early scoliosis.The journal of bone & joint surgery, volume 96-a, number 15, 1295-1302.Twenty-one children with thoracic insufficiency syndrome underwent veptr expansion thoracoplasty from 2002 to 2012.Ten of the subjects were male and eleven were female.The mean age at the index procedure was fifty-eight months (range, twenty-four to 131 months), and the mean duration of follow-up was seventy-two months (range, thirty-eight to 103 months).The etiology of the scoliosis was syndromic in six patients, congenital in eleven, neuromuscular in three, and idiopathic in one.During the study period, there were no neural or vascular complications.Eleven implant related complications required unplanned surgical procedures.Five of these were performed for implant complications such as implant dislodgement or rod breakage.The remaining six were performed for wound revisions; three of these were performed for deep infection and three for skin breakdown secondary to implant prominence.Three patients underwent veptr device removal without replacement.In one of these patients, a pelvis-to-rib device was removed because a ct scan showed extensive spontaneous fusion and the device was deemed no longer necessary.However, despite the observed fusion, the patient showed increased coronal imbalance after device removal.In the second patient, a rib-to-rib device was removed because of skin compromise.In the third patient, a pelvis-to-rib device was removed to eradicate an implant related infection.All three patients had worsening of deformity after removal.One of these patients has already undergone posterior instrumented arthrodesis, and definitive posterior instrumented arthrodesis is planned for the other two patients.Fvc improved over time; however, this increase in lung volume did not keep up with the growth of the child as the percentage of the predicted fvc decreased, and the chest wall stiffness increased.Coronal correction was maintained, but the increase in proximal thoracic kyphosis is concerning.This report for five implant complications such as implant dislodgement or rod breakage in unspecified patients.This is report 1 of 2 for (b)(4).This report is for unknown veptr constructs, unknown part numbers/ lot numbers.A copy of the literature abstract is being submitted with this medwatch.

Manufacturer Narrative

Ozgur dede and et al (2014): pulmonary and radiographic outcomes of veptr (vertical expandable prosthetic titanium rib) treatment in early scoliosis.The journal of bone & joint surgery, volume 96-a, number 15, 1295-1302.(b)(6).The investigation could not be completed and no conclusion could be drawn, as no devices were returned and no lot numbers or part numbers were 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: 4580191
• MDR Text Key: 5341369
• Report Number: 2520274-2015-11520
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2015
• 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: 02/24/2015
• 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