MAUDE Adverse Event Report: ARB MEDICAL, LLC; REBOUND HRD

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.

• Type of Device: REBOUND 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 Key: 6215777
• MDR Text Key: 63853266
• Report Number: 3005770977-2016-00001
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• 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 Received: 12/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: RB-SLD-LSO-PP
• Device Lot Number: 150006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Other