MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI OFFSET LAMINA HOOK LOW PROFILE-LEFT; PROSTHESIS, RIB REPLACEMENT

Catalog Number 497.261

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant device is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4).A device history record (dhr) review was performed on part # 497.261, lot h13117: dhr could not be completed as the reported part and lot number combination is not valid.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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that patient was initially implanted with vertical expandable prosthetic titanium rib (veptr) system on (b)(6) 2013.Postoperatively, on an unknown date it was identified that the distal lumber hook was loosened.Replacement surgery was performed on (b)(6) 2013.On (b)(6) 2014, it was found that the lumber hook, which was placed at l2, was loosened and unhooked.On (b)(6) 2014, the second replacement surgery was performed.The hook in question was replaced with a pedicle screw for fixing at l1-l2.No problems have occurred since then.The rest of the components of the veptr system other than the hook are remaining in the patient¿s body.According to the surgeon, the hook might not be able to work properly as the patient¿s bones are too small.Patient status reported as good.The first replacement surgery performed on (b)(6) 2013 has been captured under linked complaint (b)(4).This report addresses the second revision surgery which was performed on (b)(6) 2014 due to lumber hook loosened and unhooked.This report is for one (1) ti offset lamina hook low profile-left.This is report 1 of 1 for complaint (b)(4).

• Brand Name: TI OFFSET LAMINA HOOK LOW PROFILE-LEFT
• 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: 6578844
• MDR Text Key: 75594171
• Report Number: 2530088-2017-10115
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 07611819747678
• UDI-Public: (01)07611819747678(10)H131171
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 04/24/2017

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 497.261
• Device Lot Number: H131171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2017
• Initial Date FDA Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR
• Patient Weight: 12