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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
Model Number N/A
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/07/2021
Event Type  malfunction  
Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference reports 3003853072-2021-00009 to 3003853072-2021-00014.
 
Event Description
It was reported that six closure top threads stripped during an operation.The plugs were replaced and the surgery was completed.There was no reported patient impact.This is report five of six for this event.
 
Event Description
It was reported that six closure top threads stripped during an operation.The plugs were replaced and the surgery was completed.There was no reported patient impact.This is report five of six for this event.
 
Manufacturer Narrative
Corrections: h3 additional information: h6, component codes, type of investigations, findings, conclusions.Device evaluation: visual inspection revealed all six returned devices have damaged threads.Potential cause: root cause was unable to be determined.This event could possibly be attributed to cross threading during use.Dhr review: per dhr review, the part was likely conforming when it left zimmer biomet control.Device usage: this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
 
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Brand Name
BLOCKER
Type of Device
INSTINCT JAVA SYSTEM
Manufacturer (Section D)
ZIMMER SPINE
23 parvis des chartrons
cite mondiale
bordeaux, cedex 33080
FR  33080
MDR Report Key11398678
MDR Text Key234307355
Report Number3003853072-2021-00013
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K111301
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number046W0AN00002
Device Lot NumberV16002760
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/24/2021
Was the Report Sent to FDA? No
Date Manufacturer Received07/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Weight68
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