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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE POLYAXIAL PEDICLE SCREW Ø6.5 LG 45; INSTINCT JAVA SYSTEM
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ZIMMER SPINE POLYAXIAL PEDICLE SCREW Ø6.5 LG 45; INSTINCT JAVA SYSTEM Back to Search Results
Catalog Number 046W0AN26545
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2021
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 3003853072-2021-00094 through 3003853072-2021-00097.
 
Event Description
It was reported the threads of three blockers and one pedicle screw were damaged intra-op.They were removed and replaced with alternate closure tops and a screw to complete the procedure without patient impacts.This is report four of four for this event.
 
Manufacturer Narrative
Device evaluation: the returned was evaluated and there were no signs of damage.A functional check found a mating blocker was able to thread completely into the tulip without issue.No device problems were found.Potential cause no device problems were found.Dhr review per dhr review, the part was likely conforming when it left zimmer biomet control.Device use this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
 
Event Description
It was reported the threads of three blockers and one pedicle screw were damaged intra-op.They were removed and replaced with alternate closure tops and a screw to complete the procedure without patient impacts.This is report four of four for this event.
 
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Brand Name
POLYAXIAL PEDICLE SCREW Ø6.5 LG 45
Type of Device
INSTINCT 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
kim martinez
10225 westmoor dr.
na
westminster, CO 80021
3035144809
MDR Report Key12361467
MDR Text Key267931917
Report Number3003853072-2021-00097
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K111301
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number046W0AN26545
Device Lot NumberH37055B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/14/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Weight70 KG
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