Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5 TI 6.5X45MM TRANSLATION SCREW; POLARIS SPINAL SYSTEM -TRANSLATION SCREW
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER BIOMET SPINE INC. 5.5 TI 6.5X45MM TRANSLATION SCREW; POLARIS SPINAL SYSTEM -TRANSLATION SCREW Back to Search Results
Catalog Number 14-578445
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 fifteen of sixteen.
 
Manufacturer Narrative
Additional information: b2, b5, h1, h6 (patient code).
 
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.Additional information was provided which stated the patient has passed away due to covid-19 and it is not believed that the polaris construct contributed to the patient¿s passing.This is report fifteen of sixteen.
 
Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow-up report will be sent upon completion of the device evaluation.
 
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 fifteen of sixteen.
 
Event Description
A subsequent additional update was reported stating that the patient has not passed away but was admitted to the er for a l5 pedicle fracture and vertebral body fracture and was reported to be bedridden.No procedures have been scheduled, and the most recently received update was that the patient was discharged from the hospital.
 
Manufacturer Narrative
Correction to h1.Additional information: b5, h6 (patient code).
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed for 16 returned translation screws for the reported failure of trolley failure due to reaction with spf, allowing the screws to disassemble in-vivo.The dhrs were reviewed.There are no indications of manufacturing issues that would have contributed to this event and the screws were likely conforming when they left zimmer biomet¿s control.The associated ifu was updated and the user was notified.An internal capa is investigating the cause.
 
Event Description
It was reported that 16 translating 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 standard polyaxial screws.There were no additional patient impacts reported with this event.This is report fifteen of sixteen for this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
5.5 TI 6.5X45MM TRANSLATION SCREW
Type of Device
POLARIS SPINAL SYSTEM -TRANSLATION SCREW
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key10330507
MDR Text Key200601403
Report Number3012447612-2020-00374
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K140123
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
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 Health Professional
Device Catalogue Number14-578445
Device Lot Number2350671
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2020
Was the Report Sent to FDA? No
Date Manufacturer Received02/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-0570-2021
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization; Other; Required Intervention;
-
-