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

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.

• Type of Device: ROD, 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 Key: 7359563
• MDR Text Key: 103130735
• Report Number: 3025141-2018-00127
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• 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 Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention