MAUDE Adverse Event Report: SYNTHES USA TI PROXIMAL EXTENSION SIZE 5/500MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.641.055

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported by the surgeon that the vertical expandable prosthetic titanium rib (veptr) ii rib-spine construct failed in a patient.Patient was reported to be very small and was implanted with size 7 on an unknown date.It was discovered that the rib-sleeve portion of proximal extension was broken within a month of extension surgery.The date of event was estimated to be early (b)(6), 2015.It is unknown if the patient underwent unplanned revision or additional intervention due to the event.This report is for an unknown veptr rib sleeve.This is report 1 of 1 for (b)(4).

Event Description

Update: it was reported that an unknown part/device was explanted during a planned lengthening procedure on (b)(6) 2015.A proximal extension was then replaced.

Manufacturer Narrative

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.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.

Manufacturer Narrative

Device 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 PROXIMAL EXTENSION SIZE 5/500MM RADIUS
• 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: 4916009
• MDR Text Key: 6015061
• Report Number: 2520274-2015-14908
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK142587
• 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: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.641.055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2015
• 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
• Treatment: UNKNOWN ¿ VEPTR, RIB HOOK