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U.S. Department of Health and Human Services

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

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ACUMED LLC PLATE, FIXATION, BONE Back to Search Results
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.
 
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Type of DevicePLATE, 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 Key9527129
MDR Text Key172927491
Report Number3025141-2019-00701
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received12/27/2019
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 Received12/23/2019
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
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