MAUDE Adverse Event Report: ACUMED LLC; PLATE, FIXATION, BONE

Device Problem Material Rupture (1546)

Patient Problem Rupture (2208)

Event Type  Injury  

Event Description

A flexor tendon rupture occurred following implantation of an aculoc distal radius plate; explantation was performed.Reported in the journal of bone and joint surgery.

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 9432
• Manufacturer (Section G): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 9432
• Manufacturer Contact: micki lehman ; 5885 nw cornelius pass road; hillsboro, OR 97124-9432 ; 5036279957
• MDR Report Key: 5414172
• MDR Text Key: 37612071
• Report Number: 3025141-2016-00033
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K102998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 01/20/2016
• Initial Date FDA Received: 02/05/2016
• 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