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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC ACUTRAK SCREW; SCREW, FIXATION, BONE
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ACUMED LLC ACUTRAK SCREW; SCREW, FIXATION, BONE Back to Search Results
Device Problem Unexpected Therapeutic Results (1631)
Patient Problems Bone Fracture(s) (1870); Impaired Healing (2378)
Event Type  malfunction  
Manufacturer Narrative
Additional mdrs associated with this article: 3025141-2019-00084: case 1, 3025141-2019-00085: case 2, 3025141-2019-00095: case 4, 3025141-2019-00096: case 5.
 
Event Description
Following implantation of an acutrak screw, the patient, an athlete, experienced delayed wound healing proximal to the screw insertion site.Resolved at 3 weeks postoperatively.Case 3.From: article: headless compression screw fixation of jones fractures.Nagao, masashi; saita, yoshitomo; kameda, so; seto, hiroaki; sadatsuki, ryo; takazawa, yuji; yoshimura, masafumi; aoba, yukhiro; ikdea, hiroshi; kaneko, kazuo; nozawa, masahiko; kim, sung-gon.American journal of sports medicine, 2012, vol.40, no.11, 2578-2582.
 
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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 Key8298951
MDR Text Key134926920
Report Number3025141-2019-00094
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received01/22/2019
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 Number1
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