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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 Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/02/2016
Event Type  malfunction  
Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted. 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 3003853072-2016-00167 - 3003853072-2016-00174.
 
Event Description
It was reported that the threads of eight blockers were damaged during final tightening. There was a minor surgical delay while the blockers were removed and replaced with additional copies, but there are no reports of patient injury associated with this event. This is report five of eight for this event.
 
Manufacturer Narrative
The device was not returned for evaluation, however photos of the device were provided and reviewed. The threads were damaged in a manner consistent with cross-threading. A review of the manufacturing records did not identify any issues which would have contributed to this event. The labeling was reviewed and found to contain instructions regarding proper device usage.
 
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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 Key6190152
MDR Text Key62856137
Report Number3003853072-2016-00171
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeCH
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 06/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number046W0AN00002
Device Lot NumberE86252
Other Device ID Number(01)00889024339910
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 Received05/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/22/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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