MAUDE Adverse Event Report: SYNTHES BRANDYWINE 90 DEG TI S-HOOK/RIGHT; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.601.000

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.Patient id & dob not provided for reporting.Explant date: not explanted.Device is not expected to be returned for manufacturer review/investigation.Initial reporter's phone number: (b)(6).Patient code used for: 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.A device history record (dhr) review was performed for the affected lot: 04.601.000 / 6648675; mfg.Date; 04/07/2011, no abnormalities or deviations were detected, which could lead to the complaint failure.Dhr review found no relevant issues that would result in this product complaint 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).(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.(b)(6) 2012 the post-operative infection on the wounded are was confirmed.(b)(6) 2012 a necessary treatment (unknown treatment details) was performed.The patient became well.(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 16 parts.This report is 1 of 16 for (b)(6.

Manufacturer Narrative

Date transposed, correction from jul 4, 2011 to apr 7, 2011.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: 90 DEG TI S-HOOK/RIGHT
• 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: 6616708
• MDR Text Key: 76821843
• Report Number: 2530088-2017-10162
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 07611819868601
• UDI-Public: (01)07611819868601(10)6648675
• 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

• 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: 6648675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2017
• Initial Date FDA Received: 06/06/2017
• Supplement Dates Manufacturer Received: 08/03/2017
• Supplement Dates FDA Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 MO
• Patient Weight: 16