MAUDE Adverse Event Report: ACUMED LLC ACUTRAK SCREW; SCREW, FIXATION, BONE

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Additional mdr's associated with this article: 3025141-2019-00060: case 1; 3025141-2019-00061: case 2; 3025141-2019-00062: case 3; 3025141-2019-00064: case 5.

Event Description

Following implantation of an acutrak screw, the patient experienced scaphoid non union.Revision surgery (wrist fusion and four corner fusion) was performed due to progressive wrist pain.Case 4.From: article: acutrak versus herbert screw fixation for scaphoid non-union and delayed union.Oduwole, kayode; cichy, benedickt; dillion, john p; wilson, joan; o'beirne, john.Journal of orthopaedic surgery 2012; 20(1): 61 - 5.

• Brand Name: ACUTRAK SCREW
• Type of Device: SCREW, FIXATION, BONE
• 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 ; 8886279957
• MDR Report Key: 8290238
• MDR Text Key: 134561397
• Report Number: 3025141-2019-00063
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2019
• 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