MAUDE Adverse Event Report: SYNTHES USA TI RIB HOOK CAP/EXTRA LONG; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.641.006

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Failure of Implant (1924)

Event Date 09/22/2014

Event Type  malfunction  

Event Description

It was reported that during a planned lengthening procedure of the vertical expandable prosthetic titanium rib (veptr) ii device on (b)(6) 2014, the titanium rib hook cap extra long was noticed to be dislodged from the titanium rib hook 20mm extension.The underlying hooks were still solid enough to remain implanted and the surgeon was able to make the necessary lengthening using the current construct.The dislodged parts will be replaced during a future revision, unless they become prominent prior to that time.There were no reports of a time delay.This report is 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot 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

(b)(4).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.

• Brand Name: TI RIB HOOK CAP/EXTRA LONG
• 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: 4183820
• MDR Text Key: 17614365
• Report Number: 2520274-2014-14188
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.641.006
• 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 Age: 7 YR