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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC 3.0MM X 270MM ULNA ROD ROD, FIXATION, INTRAMEDULLARY

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ACUMED LLC 3.0MM X 270MM ULNA ROD ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number UL-3027-S
Device Problem Bent (1059)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
Additional mdrs associated with this event: 3025141-2018-00234: radius 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
Additional mdrs associated with this event: 3025141-2018-00234: radius rod, follow up 1. 3025141-2018-00251: screw.
 
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Brand Name3.0MM X 270MM ULNA ROD
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 Key7580459
MDR Text Key110452773
Report Number3025141-2018-00232
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 Expiration Date05/31/2019
Device Model NumberUL-3027-S
Device Catalogue NumberUL-3027-S
Device Lot Number274414
Was Device Available for Evaluation? No
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? Device Not Returned to Manufacturer
Date Device Manufactured05/21/2012
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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