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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. OPEN-OPEN SADDLE PARALLEL DOMINO 5.5 X 5.5MM, 0 DEG; POLARIS SPINAL SYSTEM
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ZIMMER BIOMET SPINE INC. OPEN-OPEN SADDLE PARALLEL DOMINO 5.5 X 5.5MM, 0 DEG; POLARIS SPINAL SYSTEM Back to Search Results
Catalog Number 14-589607
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2022
Event Type  malfunction  
Event Description
Two polaris 4.75 dominos were returned with the pieces reported on 3012447612-2022-00086 through 3012447612-2022-00095, and were also found to have damaged threads.There were no reported patient impacts.This is report two of two for this event.
 
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 report 3012447612-2022-00157.
 
Event Description
Two polaris 4.75 dominos were returned with the pieces reported on 3012447612-2022-00086 through 3012447612-2022-00095, and were also found to have damaged threads.There were no reported patient impacts.This is report two of two for this event.
 
Manufacturer Narrative
Device evaluation: visual inspection revealed damage to the threading of all the returned devices.There was no damage to the screw drives.Root cause: root cause was unable to be determined.This event could possibly be attributed to inserting the closure tops off-axis and cross threading them, and then continuing to attempt installation on cross-threaded screws.Dhr review: per dhr review, the parts were likely conforming when they left zimvie control.Device usage: 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.
 
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Brand Name
OPEN-OPEN SADDLE PARALLEL DOMINO 5.5 X 5.5MM, 0 DEG
Type of Device
POLARIS SPINAL SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
Manufacturer (Section G)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
na
westminster CO 80021
Manufacturer Contact
kim martinez
10225 westmoor dr.
na
westminster, CO 80021
3035144809
MDR Report Key14732708
MDR Text Key294262997
Report Number3012447612-2022-00158
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00880304926189
UDI-Public(01)00880304926189(10)3072011
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K133746
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 08/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number14-589607
Device Lot Number3072011
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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