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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5 TI 6.5X50MM TRANSLATION SCREW POLARIS SPINAL SYSTEM -TRANSLATION SCREW

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ZIMMER BIOMET SPINE INC. 5.5 TI 6.5X50MM TRANSLATION SCREW POLARIS SPINAL SYSTEM -TRANSLATION SCREW Back to Search Results
Catalog Number 14-578450
Device Problems Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Death (1802); Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); No Code Available (3191)
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 3012447612-2020-00360 to 3012447612-2020-00375.
 
Event Description
It was reported that 16 polaris screws were found to have disassembled postoperatively after the patient reported pain and discomfort. A revision was preformed where all screws were removed and replaced with alternate polaris screws. Additionally, during the revision, all 16 plugs were found to have migrated or loosened from the screws. There were no additional patient impacts reported. This is report thirteen of sixteen.
 
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Brand Name5.5 TI 6.5X50MM 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
ashley krieger
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key10330505
MDR Text Key200601381
Report Number3012447612-2020-00372
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140123
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number14-578450
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/12/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberZ-0570-2021

Patient Treatment Data
Date Received: 07/27/2020 Patient Sequence Number: 1
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