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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 Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Type  Injury  
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 3003853072-2019-00102 to 3003853072-2019-00111.
 
Event Description
It was reported that a patient underwent a revision surgery to remove an old java construct that was implanted years earlier. The complainant stated that there was no fusion present at the time of removal and a new construct was placed to complete the case. No further specific surgical or patient information was provided. This is report six of ten.
 
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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 Key9258224
MDR Text Key179308276
Report Number3003853072-2019-00107
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJO
PMA/PMN Number
K111301
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received09/23/2019
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 Invalid Data

Patient Treatment Data
Date Received: 10/30/2019 Patient Sequence Number: 1
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