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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 7.5 X 45MM MULTI-AXIAL SCREW, 5.5 SST; POLARIS SPINAL SYSTEM
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ZIMMER BIOMET SPINE INC. 7.5 X 45MM MULTI-AXIAL SCREW, 5.5 SST; POLARIS SPINAL SYSTEM Back to Search Results
Catalog Number 14-502545
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bone Fracture(s) (1870)
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 reports 3012447612-2020-00597.
 
Event Description
It was reported that the patient was admitted to the er for l5 pedicle and vertebral body fractures.The patient is reported to be bedridden and there are no plans to revise at this time.This is report 1 of 2.
 
Event Description
It was reported that the patient was admitted to the er for l5 pedicle and vertebral body fractures.The patient is reported to be bedridden and there are no plans to revise at this time.This is report 1 of 2.
 
Manufacturer Narrative
The complaint is confirmed for two polaris translating screws for the failure of patient harm after surgery.Medical records were not provided for review.Device evaluation: screws were not returned for evaluation and no photos were provided, so a device evaluation could not be completed.Potential cause: root cause was unable to be determined.This event could possibly be patient condition from previous surgeries.Dhr review and related actions: the dhrs were unable to be reviewed since the lot numbers are unknown.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.
 
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Brand Name
7.5 X 45MM MULTI-AXIAL SCREW, 5.5 SST
Type of Device
POLARIS SPINAL SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key10653410
MDR Text Key210576327
Report Number3012447612-2020-00596
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K090523
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 02/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number14-502545
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
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