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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 Migration or Expulsion of Device (1395)
Patient Problem Blood Loss (2597)
Event Date 11/23/2016
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.
 
Event Description
It was reported that a rod was not properly retained by the closure top, allowing the rod to move, and caused excessive bleeding to the patient. A revision surgery is planned to correct this issue.
 
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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
teresa george
310 interlocken pkwy ste. 120
na
broomfield, CO 80021
3034437500
MDR Report Key6190248
MDR Text Key62852625
Report Number3003853072-2016-00166
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
PK111301
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number046W0AN00002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2017
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

Patient Treatment Data
Date Received: 12/20/2016 Patient Sequence Number: 1
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