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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC PLATE, FIXATION, BONE

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ACUMED LLC PLATE, FIXATION, BONE Back to Search Results
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Additional mdrs associated with this event: 3025141-2020-00038: tap, 3025141-2020-00039: plate 1, 3025141-2020-00041: plate 3.
 
Event Description
During removal of an elbow plate (removal reason is not known), several foreign bodies were found and removed. The surgeon believes the foreign bodies formed around metal shavings from the plate that formed while using the plate tap in the most distal holes of the medial and lateral elbow plates.
 
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Type of DevicePLATE, 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
MDR Report Key9763743
MDR Text Key182229738
Report Number3025141-2020-00040
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2020
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 Received02/10/2020
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: 02/27/2020 Patient Sequence Number: 1
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