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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE BLOCKER INSTINCT JAVA SYSTEM

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ZIMMER SPINE BLOCKER INSTINCT JAVA SYSTEM Back to Search Results
Catalog Number 046W0AN00002
Device Problem Installation-Related Problem (2965)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/27/2019
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 report number 3003853072-2019-00088.

 
Event Description

It was reported that during the procedure the driver tip broke while tightening the blockers. One blocker in the procedure was not tightened as a result of the breakage. There were no reported patient impacts. This is report one of two for this event.

 
Manufacturer Narrative

The device was not returned for evaluation, so no results are available and no conclusions can be drawn. The lot number is unknown; therefore the device history records are unable to be reviewed.

 
Event Description

It was reported that during the procedure the driver tip broke while tightening the blockers. One blocker in the procedure was not tightened as a result of the breakage. There were no reported patient impacts. This is report one of two for this event.

 
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Brand NameBLOCKER
Type of DeviceINSTINCT JAVA SYSTEM
Manufacturer (Section D)
ZIMMER SPINE
23 parvis des chartrons
cite mondiale
bordeaux, cedex 33080
FR 33080
Manufacturer (Section G)
ZIMMER SPINE
23 parvis des chartrons
cite mondiale
bordeaux, cedex 33080
FR 33080
Manufacturer Contact
ashley mcpherson
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key9118200
MDR Text Key168056595
Report Number3003853072-2019-00087
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeLE
PMA/PMN NumberK111301
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/05/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/25/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number046W0AN00002
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/06/2020
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

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