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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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ACUMED LLC ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Device Problem Device Inoperable (1663)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Additional mdr's from this article: 3025141-2018-00130: case 1; 3025141-2018-00131: case 2; 3025141-2018-00132: case 3; 3025141-2018-00133: case 4; 3025141-2018-00134: case 5; 3025141-2018-00135: case 6; 3025141-2018-00136: case 7; 3025141-2018-00138: case 9; 3025141-2018-00139: case 10; 3025141-2018-00140: case 11.
 
Event Description
Patient with fractures of the radius or both the radius and the ulna was treated with intramedullary nails. There was complications in that the epl tendon was not functioning. The article does not indicate what treatment was given. Reference: the effects of radial bowing and complications of intramedullary nail fixation of adult forearm fractures. Ali cagdas yorukoglu, ahmet fahir demirkan, alp akman, ali kitis, hande usta. Joint diseases and related surgery. 2017; 28(1):30-34.
 
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Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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 lehman
5885 ne cornelius pass road
hillsboro, OR 97124
8886279957
MDR Report Key7359884
MDR Text Key103137773
Report Number3025141-2018-00137
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K915613
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 03/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2018
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? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/08/2018
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: 03/21/2018 Patient Sequence Number: 1
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