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

Device Problem Insufficient Information (3190)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs from this article: 3025141-2018-00130: case 1; 3025141-2018-00131: case 2; 3025141-2018-00132: case 3; 3025141-2018-00134: case 5; 3025141-2018-00135: case 6; 3025141-2018-00136: case 7; 3025141-2018-00137: case 8; 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 tendon was torn during surgery.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.

• 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: 7359879
• MDR Text Key: 103137718
• Report Number: 3025141-2018-00133
• 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): Other