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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 Appropriate Term/Code Not Available (3191)
Patient Problems Bone Fracture(s) (1870); Joint Dislocation (2374)
Event Type  Injury  
Manufacturer Narrative
Additional mdr's associated with this article: 3025141-2018-00201: case 1; 3025141-2018-00203: case 3; 3025141-2018-00204: case 4; 3025141-2018-00205: case 5; 3025141-2018-00206: case 6; 3025141-2018-00211: case 7; 3025141-2018-00212: case 8; 3025141-2018-00213: case 9; 3025141-2018-00214: case 10; 3025141-2018-00215: case 11; 3025141-2018-00216: case 12; 3025141-2018-00217: case 13; 3025141-2018-00220: case 14; 3025141-2018-00221: case 15; 3025141-2018-00222: case 16; 3025141-2018-00224: case 17; 3025141-2018-00225: case 18; 3025141-2018-00226: case 19; 3025141-2018-00227: case 20; 3025141-2018-00228: case 21.
 
Event Description
Patient with a fracture of the fibula was treated with a fibula rod. Significant failure of fixation occurred, with shortening of the fibula and lateral subluxation of the talus. Revised to ankle fusion. Reference: bugler, k. E. , et al. , the treatment of unstable fractures of the ankle using the acumed fibular nail: development of a technique. J bone joint surg br, 2012. 94(8): p. 1107-12.
 
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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 Key7527728
MDR Text Key108724051
Report Number3025141-2018-00202
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K951673
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 05/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2018
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 Received05/08/2018
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: 05/18/2018 Patient Sequence Number: 1
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