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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
Address: establishment name: ((b)(6) hospital).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 3003853072-2020-00059.
 
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 two of two for this event.
 
Manufacturer Narrative
(b)(4).The complaint is confirmed the reported failure of wear.Visual inspection revealed that the plug was worn on both the head and threads.The damage to the threads of the plugs and the screw tulip head are consistent with cross-threading of the plugs into the screw tulip head during attempted installation.However, a definitive root cause could not be determined.Per dhr review, the part was likely conforming when it left zimmer biomet control.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report.
 
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 two of two for this event.
 
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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 Key10242845
MDR Text Key197992004
Report Number3003853072-2020-00060
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00889024339910
UDI-Public(01)00889024339910(10)E141576(11)170721
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,Followup
Report Date 09/28/2020
1 Device was Involved in the Event
1 Patient was 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
Was the Report Sent to FDA? No
Date Manufacturer Received09/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Weight71
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