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

Device Problem Activation Failure (3270)

Patient Problem Failure of Implant (1924)

Event Date 01/14/2014

Event Type  Injury  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during the initial surgery on (b)(6) 2010, the cradle type veptr (vertical expandable prosthetic titanium rib) was set for the sixth through the tenth right rib and the hybrid veptr was set for the right forth rib through the forth lumbar vertebrae.On (b)(6) 2014, kyphosis at the junction was determined, as the patient was taking a wait and see approach.It was also reported that on (b)(6) 2014 during a preoperative examination; it was determined that the kyphosis worsened.At this time, the removal of veptr was decided due to the uncontrolled expansion of the veptr system.On (b)(6) 2014, the entire veptr system was extracted and the growing rod was replaced.There was no report of implanted parts being left inside of the patient or a report of any surgical delay.This report is for an unknown veptr.This report is 1 of 1 complaint (b)(4).

Manufacturer Narrative

Device was used for treatment.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: 3781763
• MDR Text Key: 4444001
• Report Number: 2520274-2014-11141
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• 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: 04/03/2014
• 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
• Patient Age: 8 YR