MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI LUMBAR EXTENSION SIZE 11/220MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Catalog Number 497.252

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

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device is not expected to be returned for manufacturer review/investigation.(b)(6).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review has been requested.(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.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follow: it was reported that the patient underwent surgeries for adjusting veptr size on (b)(6) 2013 and (b)(6) 2014 respectively.On (b)(6) 2014, it was noticed that patient had (b)(6) infection and insufficient fusion on the wounded area.A cultivation test was performed and the result was (b)(6) on (b)(6) 2014, patient underwent removal procedure and only the veptr, stabilized between the left 5th lib and the ileum was removed.Patient outcome was reported as well.Reportedly, the veptr treatment has continued.Patient¿s past and future patient histories are captured in linked complaints (b)(4) respectively.This report is for one (1) ti lumbar extension size 11/220mm radius.This is report 6 of 9 for (b)(4).

Manufacturer Narrative

Device history records review was completed for part# 497.252, lot# 6833548.Manufacturing location: (b)(4), manufacturing date: jan 19, 2012.The review was done for the parent lot number (6833548) and all raw material lots used to manufacture the device.Component (b)(4)¿ raw material of (b)(4), lot number 6753527.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 LUMBAR EXTENSION SIZE 11/220MM RADIUS
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6602537
• MDR Text Key: 76375911
• Report Number: 2530088-2017-10137
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 07611819747623
• UDI-Public: (01)07611819747623(10)6833548
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 497.252
• Device Lot Number: 6833548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2017
• Initial Date FDA Received: 05/31/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR
• Patient Weight: 17