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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. STANDARD CLOSURE TOP; VIRAGE OCT SPINAL FIXATION SYSTEM
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ZIMMER BIOMET SPINE INC. STANDARD CLOSURE TOP; VIRAGE OCT SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 07.01728.001
Device Problem Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/31/2018
Event Type  malfunction  
Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3012447612-2018-00979 thru 3012447612-2018-00982.
 
Event Description
It was reported that four closure tops cross-threaded during installation within surgery.They were each removed and replaced with alternative closure tops to complete the procedure without reported patient impacts.This is event three of four for this event.
 
Manufacturer Narrative
Additional information: (results and conclusions) - without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
 
Event Description
It was reported that four closure tops cross-threaded during installation within surgery.They were each removed and replaced with alternative closure tops to complete the procedure without reported patient impacts.This is event three of four for this event.
 
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Brand Name
STANDARD CLOSURE TOP
Type of Device
VIRAGE OCT SPINAL FIXATION SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
Manufacturer (Section G)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
na
westminster CO 80021
Manufacturer Contact
ashley mcpherson
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key8132821
MDR Text Key129455621
Report Number3012447612-2018-00981
Device Sequence Number1
Product Code KWP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133556
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number07.01728.001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/22/2019
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 N
Patient Sequence Number1
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