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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PLUG; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
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ZIMMER BIOMET SPINE INC. PLUG; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM Back to Search Results
Catalog Number 2000-1005
Device Problem Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/05/2020
Event Type  malfunction  
Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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 3012447612-2020-00666.
 
Event Description
It was reported that during final tightening, the driver was not completely inserted in the set screw and the tip of the driver twisted causing cross-threading of the implant and deformation of the tip of the driver.Surgery was completed with an alternate polaris plug.There were no reported patient impacts.This is report one of two for this event.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is unrefuted for one (1) of one (1) polaris plug (pn 2000-1005) for the failure of deformation due to cross-threading.Medical records were not provided for review.Device evaluation: product was not returned and photos were not provided for review.Potential cause root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review and related actions dhr review unable to be performed without a lot number.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.A follow-up report will be submitted if new information is received that changes the information provided in this report.
 
Event Description
It was reported that during final tightening, the driver was not completely inserted in the set screw and the tip of the driver twisted causing cross-threading of the implant and deformation of the tip of the driver.Surgery was completed with an alternate polaris plug.There were no reported patient impacts.This is report one of two for this event.
 
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Brand Name
PLUG
Type of Device
EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key10863873
MDR Text Key223613215
Report Number3012447612-2020-00658
Device Sequence Number1
Product Code MNH
Combination Product (y/n)N
PMA/PMN Number
K061441
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 04/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2000-1005
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/30/2020
Initial Date FDA Received11/18/2020
Supplement Dates Manufacturer Received04/01/2021
Supplement Dates FDA Received04/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age22 YR
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