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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WARSAW ORTHOPEDICS BRYAN CERVICAL DISC SYSTEM; PROSTHESIS, INTERVERTEBRAL DISC
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WARSAW ORTHOPEDICS BRYAN CERVICAL DISC SYSTEM; PROSTHESIS, INTERVERTEBRAL DISC Back to Search Results
Catalog Number 6474525
Device Problems Mechanical Problem (1384); Failure to Cut (2587)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that the item would not cut.The end plate cutting disks would not spin.The surgeon used a second cutter.No patient complications were reported.
 
Manufacturer Narrative
(b)(4): the device was not returned to the manufacturer for evaluation.
 
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Brand Name
BRYAN CERVICAL DISC SYSTEM
Type of Device
PROSTHESIS, INTERVERTEBRAL DISC
Manufacturer (Section D)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
huzefa mamoola
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key3946924
MDR Text Key15121679
Report Number1030489-2014-03261
Device Sequence Number1
Product Code MJO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P060023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/03/2021
Device Catalogue Number6474525
Device Lot NumberEM13G019
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/23/2014
Initial Date FDA Received07/21/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/11/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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