MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI DISTRACTION LOCK; PROSTHESIS, RIB REPLACEMENT

Catalog Number 497.125

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 was used for treatment, not diagnosis.Event date: unknown.Explanted date: not explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(6).The reported event required medical/surgical intervention to preclude permanent damage to a body structure.Should further information become available this determination will be reviewed accordingly.Device history records review was conducted.The report indicates that the: part 497.125 / lot 6905168.Manufacturing location: (b)(6).Manufacturing date: "03/15/2012," manufacturing date: "30apr2012".No ncrs 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 condition.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 the patient suffers from progressive scoliosis with excessive thoracic deformity (primary disease: sotos syndrome).On (b)(6) 2012 the following two stabilizations were performed.Hybrid type veptr (size 9) was applied, ranging from the right 2nd lib to the ileum.Hybrid type veptr (size 7) was applied, ranging from the right 3rd lib to the 2nd lumbar spine.On (b)(6) 2012 the post-operative infection on the wounded are was confirmed.On (b)(6) 2012 a necessary treatment (unknown treatment details) was performed.The patient became well.On (b)(6) 2013, and (b)(6) 2014, the surgeries for adjusting veptr size was performed on respective dates.(b)(6) 2014 the surgery for adjusting veptr size was performed.Superior mesenteric artery syndrome was noticed again (b)(6) 2014, however, the patient gradually became well.(b)(6) 2014 it was reported that the patient has recovered.This complaint involves (b)(4) parts.This report is 6 of 16 for (b)(4).

Manufacturer Narrative

Manufacturing date is: 03/15/2012.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 DISTRACTION LOCK
• 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: 6616837
• MDR Text Key: 76820381
• Report Number: 2530088-2017-10170
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 07611819747289
• UDI-Public: (01)07611819747289(10)6858451
• 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: 06/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 497.125
• Device Lot Number: 6858451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 MO
• Patient Weight: 16