• 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 Failure To Adhere Or Bond (1031)
Patient Problem Bone Fracture(s) (1870)
Event Type  Injury  
Event Description
Patient with fractures of both the radius and ulna was treated with intermedulary nails in the radius and ulna. There was nonunion of the ulna. The nail was removed, a plate was applied (supplemented with an autologous iliac crest bone graft) and union was achieved. Reference: plate osteosynthesis versus intramedullary nailing for both forearm bones fractures. Sang ki lee, kap jung kim, jae won lee, won sik choy. Eur j orthop surg traumatol (2014) 24:769-776.
 
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 lehman
5885 ne cornelius pass road
hillsboro, OR 97124
8886279957
MDR Report Key7359563
MDR Text Key103130735
Report Number3025141-2018-00127
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
-
-