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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5 TI 6.5X40MM TRANSLATION SCREW POLARIS SPINAL SYSTEM -TRANSLATION SCREW

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ZIMMER BIOMET SPINE INC. 5.5 TI 6.5X40MM TRANSLATION SCREW POLARIS SPINAL SYSTEM -TRANSLATION SCREW Back to Search Results
Catalog Number 14-578440
Device Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2020
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.

 
Event Description

It was reported the screw did not have polyaxial motion during surgery. There were no patient impacts.

 
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Brand Name5.5 TI 6.5X40MM TRANSLATION SCREW
Type of DevicePOLARIS SPINAL SYSTEM -TRANSLATION SCREW
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 Key11089755
MDR Text Key226658790
Report Number3012447612-2020-00694
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeSP
PMA/PMN NumberK140123
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/26/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/29/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number14-578440
Device LOT Number2573431
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/09/2021
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/22/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/15/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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