MAUDE Adverse Event Report: SYNTHES USA 90 DEG ADOLESCENT OSTEOTOMY PLATE 40MM/10MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT

Catalog Number 235.680

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The original implant procedure was performed on an unknown date the week of (b)(6) 2016.Per facility, the complainant part is not expected to be returned for manufacturer review/investigation.Investigation could not be completed and no conclusion could be drawn as no device was returned.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.

Event Description

It was reported that a patient implanted with 90-degree adolescent osteotomy plate underwent a revision procedure on (b)(6) 2016 due to secondary back-out of the plate.The plate, along with three (3) 4.5 mm cortex screws, was removed.The patient was then revised to a new locking compression proximal plate.The procedure was completed with no reported delay.The patient is reportedly stable post-operative.This report is 1 of 1 for (b)(4).

• Brand Name: 90 DEG ADOLESCENT OSTEOTOMY PLATE 40MM/10MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5477124
• MDR Text Key: 39584136
• Report Number: 2520274-2016-11450
• Device Sequence Number: 1
• Product Code: KTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK914546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 235.680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2016
• 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