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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC ROD, FIXATION, INTRAMEDULLARY

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ACUMED LLC ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Failure to Osseointegrate (1863)
Patient Problems Bone Fracture(s) (1870); Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative
Additional mdrs associated with this article: 3025141-2018-00281: case 1, 3025141-2018-00282: case 2, 3025141-2018-00283: case 3.
 
Event Description
Journal article: why fibular nailing can be an efficient treatment strategy for ao type 44-b ankle fractures in the elderly; peeperkorn, sam, md, nijs, stefaan md phd, hoekstra, harm md phd, febs. The journal of foot & ankle surgery. 2018. There were four cases with complications in the group treated with percutaneous intramedullary fibular nailing (imfn). Case 4 of 4: nonunion was diagnosed in one patient after treatment to a delayed-staged surgery protocol (surgery delayed due to use of external fixator before definitive surgery). Nonunion followed up by plate and screw implantation. The patient was an (b)(6) obese female with severely compromised soft tissues and a trimalleolar ankle luxation fracture.
 
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Type of DeviceROD, FIXATION, INTRAMEDULLARY
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
5032071387
MDR Report Key7827916
MDR Text Key118615017
Report Number3025141-2018-00285
Device Sequence Number1
Product Code HSB
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
Type of Report Initial
Report Date 08/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2018
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 Treatment Data
Date Received: 08/29/2018 Patient Sequence Number: 1
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