MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI LUMBAR EXTENSION SIZE 10/220MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Catalog Number 497.251

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 used for treatment, not diagnosis.Device is not expected to be returned for manufacturer review/investigation.(b)(6).An infection was identified which required treatment and medical/surgical intervention to preclude permanent damage to a body structure.The device history review (dhr) was performed for part number / lot number 497.251 / 6666365.Manufacture site: (b)(4) (vendor: (b)(4)).Manufacture date: 28-jun-2011.No ncrs or scrap were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.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 on an event in (b)(6) as follows: it was reported that on (b)(6) 2012 the patient underwent surgeries for the following: two (2) stabilizations were performed.Hybrid type veptr (size 10) was applied, ranging from the left 5th lib to the ileum.Hybrid type veptr (size 7) was applied, ranging from the left 7th lib to the 3rd lumbar spine.On (b)(6) 2012, a decrease in mep was noticed.(b)(6) 2012, the poser-operative infection on the wounded area was confirmed.A necessary treatment (unknown treatment details) was performed.The patient's outcome was reported as well.This complaint involves (16) parts.Patient¿s past and future histories are captured and linked in these complaints: 1 of 3 ((b)(4)).This report is 15 of 16 for (b)(4).

Manufacturer Narrative

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.

• Brand Name: TI LUMBAR EXTENSION SIZE 10/220MM 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: 6603575
• MDR Text Key: 76377089
• Report Number: 2530088-2017-10156
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 07611819747616
• UDI-Public: (01)07611819747616(10)6666365
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 497.251
• Device Lot Number: 6666365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR
• Patient Weight: 16