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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5 MIS HF TI PLUG; POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM
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ZIMMER BIOMET SPINE INC. 5.5 MIS HF TI PLUG; POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM Back to Search Results
Catalog Number 14-500500
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/10/2020
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 report 3012447612-2020-00682.
 
Event Description
It was reported that the threads of one plug were damaged and the tulip of a pedicle screw was splayed/bent during installation in surgery.They were removed and replaced with another screw and plug to complete the procedure.There were no reported patient impacts.This is report two of two for this event.
 
Manufacturer Narrative
Additional information in d4: udi number, h4, and h6: method, results, and conclusions.This follow-up report is being submitted to relay additional information.The plug was not returned, however a photo was provided and reveals that the thread is fractured.Potential cause: since the products were not returned, the root cause can't be established.Dhr review and related actions per dhrs review, the parts were likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use: this device is used for treatment.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 that the threads of one plug were damaged and the tulip of a pedicle screw was splayed/bent during installation in surgery.They were removed and replaced with another screw and plug to complete the procedure.There were no reported patient impacts.This is report two of two for this event.
 
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Brand Name
5.5 MIS HF TI PLUG
Type of Device
POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key10971240
MDR Text Key226658861
Report Number3012447612-2020-00683
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K123549
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 02/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number14-500500
Device Lot NumberJ6560316
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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