MAUDE Adverse Event Report: ACUMED LLC PLATE, FIXATION, BONE

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this article: 3025141-2019-00702: case 2, 3025141-2019-00703: case 3, 3025141-2019-00704: case 4, 3025141-2019-00705: case 5, 3025141-2019-00706: case 6, 3025141-2019-00707: case 7, 3025141-2019-00708: case 8, 3025141-2019-00709: case 9, 3025141-2019-00710: case 10, 3025141-2019-00711: case 11, 3025141-2019-00712: case 12, 3025141-2019-00713: case 13.

Event Description

Article: surgical treatment of displaced midshaft clavicular fractures with precontoured plates; ranalletta, maximiliano, md; rossi, luciano a. , md; bongiovanni, santiago l. , md; tanoira, ignacio, md; piuzzi, nicolas s. , md; maignon, gaston, md; j should elbow surg (2015) 24, 1036-1040. Case 1: patient's broken clavicle was treated by implanting an acumed midshaft clavicle plate. Patient experienced subclavian vein compression due to a long screw that protruded from clavicle; hardware removed.

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 9527129
• MDR Text Key: 172927491
• Report Number: 3025141-2019-00701
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/23/2019
• 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 Treatment Data

Date Received: 12/27/2019 Patient Sequence Number: 1