Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE BLOCKER; INSTINCT JAVA SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER SPINE BLOCKER; INSTINCT JAVA SYSTEM Back to Search Results
Catalog Number 046W0AN00002
Device Problem Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/24/2020
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: 3003853072-2020-00105 and 3003853072-2020-00106.
 
Event Description
It was reported that two blockers were found to have stripped threads during surgery.New plugs were used to complete the operation.There was no reported patient impact.This is report one of two for this event.
 
Event Description
It was reported that two blockers were found to have stripped threads during surgery.New plugs were used to complete the operation.There was no reported patient impact.This is report one of two for this event.
 
Manufacturer Narrative
Additional information in h6: method, results, and conclusions.Both devices match information listed in the complaint file.Visual inspection of the devices shows that both have damaged outer threads that are bent.The complaint is confirmed.The devices are used for treatment.The dhrs were reviewed.There are no indications of manufacturing issues which would have contributed to this event and the devices were likely conforming when they left zimmer biomet¿s control.A definitive root cause cannot be determined with the information provided.It is possible that the blockers were cross-threaded into the mating pedicle screws during attempted installation.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10712769
MDR Text Key213402827
Report Number3003853072-2020-00105
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00889024339910
UDI-Public(01)00889024339910(10)V17067(11)171214
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 02/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number046W0AN00002
Device Lot NumberV17067
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2020
Was the Report Sent to FDA? No
Date Manufacturer Received02/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age60 YR
Patient Weight68
-
-