MAUDE Adverse Event Report: SYNTHES BRANDYWINE 90 DEG TI S-HOOK/RIGHT

Catalog Number 04.601.000

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported on (b)(6) 2013; that the patients with vertical expandable prosthetic titanium rib had to be extended again - last time was in (b)(6) this year.Last time in (b)(6) the same implant broke 3 weeks after the operation where he was extended.When they opened the patient this time the ala hook was broken again.This little boy is very active - plays soccer.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Implanted on unknown date in (b)(6) 2012.The device was received and is currently in the evaluation process.A review of device history records was performed and no complaint related issues were found during manufacturing that would contribute to this complaint.Placeholder.

• Brand Name: 90 DEG TI S-HOOK/RIGHT
• 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: gabriel szasz ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3577083
• MDR Text Key: 4076558
• Report Number: 2530088-2013-01361
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: H030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/20/2013

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: Health Professional
• Device Catalogue Number: 04.601.000
• Device Lot Number: 7143618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2013
• Initial Date FDA Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR
• Patient Weight: 20