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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported ingrave science of the patient¿s primary curvature was detected preoperatively through x-p on (b)(6) 2014.On (b)(6) 2014, the surgeon removed all the implanted veptr and implanted growing-rod.The vertical expandable prosthetic titanium rib (veptr) system implanted on the fifth rib to the lumber spine (left side) was initially used in the replacement surgery on (b)(6) 2012.This report is for the unknown veptr.This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Class iii devices for eu has an unknown, udi number.This report is for the veptr system, part and lot number unknown.First device was reported to be implanted on (b)(6) 2010 and was most likely removed on the (b)(6) 2012 date reported when the revision took place with the expandable system.The new device with the implanted growing rod appears to have been implanted on (b)(6) 2014 and the revision device from (b)(6) 2012 was explanted at this time.These dates are not clear and have not been added to implant date and explant date.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: 4285764
• MDR Text Key: 19762671
• Report Number: 2520274-2014-15001
• 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: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2014
• 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: 9 YR