• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ACUMED LLC ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
Additional mdrs associated with this article: 3025141-2020-00303: case 1, 3025141-2020-00305: case 3, 3025141-2020-00306: case 4, 3025141-2020-00307: case 5, 3025141-2020-00308: case 6, 3025141-2020-00309: case 7, 3025141-2020-00310: case 8, 3025141-2020-00311: case 9, 3025141-2020-00312: case 10, 3025141-2020-00313: case 11, 3025141-2020-00314: case 12, 3025141-2020-00315: case 13, 3025141-2020-00316: case 14, 3025141-2020-00317: case 15, 3025141-2020-00318: case 16, 3025141-2020-00319: case 17, 3025141-2020-00320: case 18, 3025141-2020-00321: case 19, 3025141-2020-00322: case 20, 3025141-2020-00323: case 21, 3025141-2020-00324: case 22, 3025141-2020-00325: case 23, 3025141-2020-00326: case 24, 3025141-2020-00327: case 25, 3025141-2020-00328: case 26, 3025141-2020-00329: case 27, 3025141-2020-00330: case 28, 3025141-2020-00331: case 29, 3025141-2020-00332: case 30, 3025141-2020-00333: case 31, 3025141-2020-00334: case 32, 3025141-2020-00335: case 33, 3025141-2020-00336: case 34, 3025141-2020-00337: case 35, 3025141-2020-00338: case 36, 3025141-2020-00339: case 37, 3025141-2020-00340: case 38, 3025141-2020-00341: case 39, 3025141-2020-00342: case 40, 3025141-2020-00343: case 41, 3025141-2020-00344: case 42, 3025141-2020-00345: case 43, 3025141-2020-00346: case 44.
 
Event Description
Article: optimizing long-term outcomes and avoiding failure with the fibula intramedullary nail; carter, thomas h. ; mackenzie, samuel p. ; bell, katrina r. , macdonald, deborah; and white, timothy o. J orthop trauma · volume 33, number 4, april 2019. Case 2: patient experienced significant failure to engage the distal fragment following implantation of a fibula nail. The nail was converted to an ilizarov frame.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 anderson
5885 ne cornelius pass road
hillsboro, OR 97124
MDR Report Key10999213
MDR Text Key221242811
Report Number3025141-2020-00304
Device Sequence Number1
Product Code HSB
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
Type of Report Initial
Report Date 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2020
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 Received11/20/2020
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: 12/13/2020 Patient Sequence Number: 1
-
-