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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUTE INNOVATIONS, LLC RIBLOC U PLUS 75MM RIB PLATE; PLATE, FIXATION, BONE
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ACUTE INNOVATIONS, LLC RIBLOC U PLUS 75MM RIB PLATE; PLATE, FIXATION, BONE Back to Search Results
Model Number RBL1302
Health Effect - Clinical Code Discomfort (2330)
Date of Event 12/22/2015
Type of Reportable Event Serious Injury
Event or Problem Description
On approximately (b)(6) 2014, seven ribloc u plus plates were successfully implanted to treat rib fractures.On (b)(6) 2015, 4 plates were removed due to patient complaints of discomfort; 3 plates were left in place.None of the plates removed were returned for investigation, however.It was stated that there was nothing wrong with the implants (plates and screws) and there was no mention by the user of an apparent installation error and yet the bones had not healed after being installed for 16 months.
 
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Brand Name
RIBLOC U PLUS 75MM RIB PLATE
Common Device Name
PLATE, FIXATION, BONE
Manufacturer (Section D)
ACUTE INNOVATIONS, LLC
21421 nw jacobson road
suite 700
hillsboro OR 97124
MDR Report Key5880977
Report Number3005670412-2016-00001
Device Sequence Number13746132
Product Code HRS
UDI-Device Identifier10814493010388
UDI-Public10814493010388
Combination Product (Y/N)N
Initial Reporter StateKS
Initial Reporter CountryUS
PMA/510(K) Number
K113318
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2015
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model NumberRBL1302
Device Catalogue NumberRBL1302
Device Lot NumberL1312007
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/22/2015
Initial Report FDA Received Date08/16/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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