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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 8.5MM X 70MM MULTIAXIAL ILIAC SCREW; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
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ZIMMER BIOMET SPINE INC. 8.5MM X 70MM MULTIAXIAL ILIAC SCREW; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM Back to Search Results
Catalog Number 14-500332
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 12/10/2020
Event Type  Injury  
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 3012447612-2020-00705.
 
Event Description
It was reported that a revision surgery was performed to address two screws that loosened post-operatively and led to a pseudoarthrosis.The screws were removed and replaced with new screws and an anterior graft.This is report one of two for this event.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The products were not returned and no photos were provided, so an evaluation is unable to be performed.As such, no evaluation results are available and no conclusions regarding the cause can be drawn.Since the screws were not returned for evaluation, the exact cause root can't be established.The 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 a revision surgery was performed to address two screws that loosened post-operatively and led to a pseudoarthrosis.The screws were removed and replaced with new screws and an anterior graft.This is report one of two for this event.
 
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Brand Name
8.5MM X 70MM MULTIAXIAL ILIAC SCREW
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 Key11120243
MDR Text Key225253905
Report Number3012447612-2020-00704
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 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number14-500332
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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