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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 Problems Material Deformation (2976); Naturally Worn (2988)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/22/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). 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 report 3003853072-2020-00060.

 
Event Description

It was reported that during the procedure the threads of two closure tops were damaged. They were removed but no further surgical information was provided. There was no reported patient harm. 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 krieger
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key10242848
MDR Text Key198014447
Report Number3003853072-2020-00059
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK111301
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 09/28/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/07/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number046W0AN00002
Device LOT NumberE141576
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/23/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/28/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/21/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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