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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC 3.0MM X 230MM RADIUS ROD, RIGHT ROD, FIXATION, INTRAMEDULLARY

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ACUMED LLC 3.0MM X 230MM RADIUS ROD, RIGHT ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number RR-3023-S
Device Problem Bent (1059)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Additional mdrs associated with this event: 3025141-2018-00232: ulna rod.
 
Event Description
A patient was involved in a motorcycle accident and broke both the ulna and radius in his arm. A radius rod and an ulna rod were implanted in a patient. Three days post op, the radius rod was found to be bent. It was explanted and the radius fracture treated with a forearm plate.
 
Manufacturer Narrative
The radius rod was examined visually. It appears to be bent in the location of the fracture in the radius. Two nicks on the rod were observed under magnification to determine their cause. The defects in the rod appear to have curved lines indicating the nicks were caused by something that was rotating, like a drill. The larger nick has some other marks on it that seems to be due to another factor. Additional mdrs associated with this event: 3025141-2018-00232: ulna rod follow up 1; 3025141-2018-00251: screw.
 
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Brand Name3.0MM X 230MM RADIUS ROD, RIGHT
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
8886279957
MDR Report Key7580465
MDR Text Key110448752
Report Number3025141-2018-00234
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K915613
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberRR-3023-S
Device Catalogue NumberRR-3023-S
Device Lot Number409648
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/17/2017
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: 06/07/2018 Patient Sequence Number: 1
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