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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 09/03/2009

Event Type  Injury  

Event Description

This report is being filed after subsequent review of the following article: samy (3 september, 2009): the effect of a vertical expandable prosthetic titanium rib on shoulder balance in patients with congenital scoliosis.J child ortho.3:391¿396.The purpose of this article was to evaluate the effect of a vertical expandable prosthetic titanium rib (veptr) on shoulder balance in patients with congenital scoliosis.Fifteen patients had a right-side congenital scoliosis (thoracic in nine patients and thoracolumbar in six patients) associated with thoracic insufficiency syndrome.The patients (11 girls and 4 boys) had a mean age of 6.4 years (range 5.3¿8.4 years) at the time of surgery.The cobb angles of the thoracic primary curves were measured.Preoperative measurements of the coracoid height difference (chd; expressed in millimeters) and the clavicular tilt angle difference (ctad; expressed in degrees) were performed for all patients.All of the patients were treated with veptr open wedge thoracostomy.For the rib to spine hybrid construct, our modified technique included the use of a pedicle screw (uss system) instead of a laminar hook (this modification was used in eight patients, two of them after the failure of the distal laminar hook during follow-up).Complications in the study were mainly related to the distal fixation point in the rib to spine veptr construct.None of the patients had any neurological complications.This report refers to two patients had dislodgement of the laminar hook, which had been observed during follow-up and hooks were replaced with pedicle screws this is report 1 of 5 for (b)(4).This report is for an unknown veptr hook, unknown part#/lot# and unknown quantity.A copy of the literature abstract is being submitted with this medwatch.

Manufacturer Narrative

Samy (3 september, 2009): the effect of a vertical expandable prosthetic titanium rib on shoulder balance in patients with congenital scoliosis.J child ortho.3:391¿396.This report is for unknown veptr hook/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: 4605312
• MDR Text Key: 5696700
• Report Number: 2520274-2015-11390
• 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