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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUTE INNOVATIONS, LLC RIBLOC U PLUS; PRIMARY GUIDE
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ACUTE INNOVATIONS, LLC RIBLOC U PLUS; PRIMARY GUIDE Back to Search Results
Model Number RBL2320
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/31/2017
Event Type  Injury  
Manufacturer Narrative
Submission based on new information received from medwatch report (b)(4).
 
Event Description
Complaint was received 12/18/2017 that an instrument, primary drill guide, had broken during reprocessing.A medwatch was filed from hospital for the same event stating: post-op imaging identified there was a retained metallic foreign body consistent with the back of the primary drill guide.The patient returned to or for removal.
 
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Brand Name
RIBLOC U PLUS
Type of Device
PRIMARY GUIDE
Manufacturer (Section D)
ACUTE INNOVATIONS, LLC
21421 nw jacobson rd
700
hillsboro OR 97124
Manufacturer (Section G)
ACUTE INNOVATIONS LLC
21421 nw jacobson rd
suite 700
hillsboro OR 97124 9374
Manufacturer Contact
veronica caldwell
21421 nw jacobson rd
suite 700
hillsboro, OR 97124-9374
5036867200
MDR Report Key7331188
MDR Text Key102117005
Report Number3005670412-2018-00001
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113318
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberRBL2320
Device Catalogue NumberRBL2320
Device Lot NumberL1509003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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