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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARB MEDICAL, LLC REBOUND HRD

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ARB MEDICAL, LLC REBOUND HRD Back to Search Results
Model Number RB-SLD-LSO-PP
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

Device was not returned to the manufacturer. Metal fatigue is suspected separation cause. This type of separation is rare (estimated at (b)(4) of devices implanted). This event is being reported because although the patient has no permanent injury or serious deterioration to health the device was removed.

 
Event Description

Eight months after implantation, patient was x-rayed. A separated frame of the device was observed on the x-ray. Device was explanted at a later date with no adverse patient effects.

 
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Type of DeviceREBOUND HRD
Manufacturer (Section D)
ARB MEDICAL, LLC
5929 baker road
suite 470
minnetonka MN 55345
Manufacturer Contact
5929 baker road
suite 470
minnetonka, MN 55345
7633547100
MDR Report Key6215777
MDR Text Key63853266
Report Number3005770977-2016-00001
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeBE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN
Reporter Occupation
Type of Report Initial
Report Date 12/28/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberRB-SLD-LSO-PP
Device LOT Number150006
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/29/2016
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: 12/30/2016 Patient Sequence Number: 1
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