MAUDE Adverse Event Report: ACUTE INNOVATIONS, LLC ACUTIE II; CERCLAGE, FIXATION

Model Number ACUTIE II

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Discomfort (2330); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Event Description

Plate was removed from patient because the surgeon apparently did not cut the wire short enough and the patient was having some discomfort.Said they always cut the wire as short as they can but this particular patient was very thin, so they're thinking this may have played a part.

• Brand Name: ACUTIE II
• Type of Device: CERCLAGE, FIXATION
• Manufacturer (Section D): ACUTE INNOVATIONS, LLC; 21421 nw jacobson road; suite 700; hillsboro OR 97124
• Manufacturer (Section G): ACUTE INNOVATIONS, LLC; 21421 nw jacobson road; suite 700; hillsboro OR 97124
• Manufacturer Contact: veronica caldwell ; 21421 nw jacobson road; suite 700; hillsoboro, OR 97124 ; 5036867200
• MDR Report Key: 6170559
• MDR Text Key: 62263651
• Report Number: 3005670412-2016-00014
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 10814493010753
• UDI-Public: 10814493010753
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ACUTIE II
• Device Catalogue Number: STW1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention