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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC OLECRANON PLATE, STANDARD 7-HOLE LT PLATE, FIXATION, BONE

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ACUMED LLC OLECRANON PLATE, STANDARD 7-HOLE LT PLATE, FIXATION, BONE Back to Search Results
Model Number 70-0306
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Type  Injury  
Event Description
An olecranon plate was implanted in the patient on (b)(6) 2017. The patient fell and fractured the bone in another location. The olecranon plate was removed and replaced with a longer plate.
 
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Brand NameOLECRANON PLATE, STANDARD 7-HOLE LT
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 lehman
5885 ne cornelius pass road
hillsboro, OR 97124
8886279957
MDR Report Key7695630
MDR Text Key114223982
Report Number3025141-2018-00262
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102998
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 07/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number70-0306
Device Catalogue Number70-0306
Device Lot Number261592
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2011
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: 07/17/2018 Patient Sequence Number: 1
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