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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. POLARIS TRANSLATION SCREW, UNKNOWN SIZE; POLARIS SPINAL SYSTEM -TRANSLATION SCREW
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ZIMMER BIOMET SPINE INC. POLARIS TRANSLATION SCREW, UNKNOWN SIZE; POLARIS SPINAL SYSTEM -TRANSLATION SCREW Back to Search Results
Catalog Number 14-5785XX
Device Problem Fracture (1260)
Patient Problems Death (1802); Bone Fracture(s) (1870); Pain (1994); Foreign Body In Patient (2687); No Code Available (3191)
Event Date 05/27/2020
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.
 
Event Description
It was reported that a polaris screw was found to have fractured postoperatively after the patient reported worsening pain.The patient underwent a revision surgery during which, the shaft of the fractured screw was not able to be retrieved and the surgeon chose to leave the shaft in the bone.There were no additional patient impacts reported.
 
Manufacturer Narrative
Additional information: b2, b5, h1, h6 (patient code).
 
Event Description
It was reported that a polaris screw was found to have fractured postoperatively after the patient reported worsening pain.The patient underwent a revision surgery during which, the shaft of the fractured screw was not able to be retrieved and the surgeon chose to leave the shaft in the bone.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.
 
Event Description
It was reported that a polaris screw was found to have fractured postoperatively after the patient reported worsening pain.The patient underwent a revision surgery during which, the shaft of the fractured screw was not able to be retrieved and the surgeon chose to leave the shaft in the bone.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.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
Additional information in b4, g7, h2, h6: results, and conclusion codes.The product was not returned, but x-ray images were provided.X-rays show a fractured s1 screw as reported.The lot number for this specific device was not provided.Therefore, the device history record (dhr) review cannot be performed in this case.It was reported that a polaris screw was found to have fractured postoperatively after the patient reported worsening pain.The patient underwent a revision surgery during which, the shaft of the fractured screw was not able to be retrieved and the surgeon chose to leave the shaft in the bone.The reported complaint is confirmed.The exact cause of this event can't be determine without the returned product and with the available information.
 
Event Description
It was reported that a polaris screw was found to have fractured postoperatively after the patient reported worsening pain.The patient underwent a revision surgery during which, the shaft of the fractured screw was not able to be retrieved and the surgeon chose to leave the shaft in the bone.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.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
(b)(4).Updated: b3, b4, b5, g4, h1, h2.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.
 
Manufacturer Narrative
Corrections in b2, b5, d4: catalog number, and h6: conclusions.Additional information in h6: component and investigation type.This report is relaying additional information.The complaint is confirmed for one (1) of one (1) polaris translation s1 screws (unknown part number) for the reported failure of fracture post-op.Without the returned product or more information about the initial surgery, a definitive cause cannot be determined.X-ray review was used to confirm the fractured screw.The part and lot number were not provided, so the dhr is unable to be reviewed and complaint history could not be evaluated.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.
 
Event Description
It was reported that a polaris screw was found to have fractured postoperatively at s1 after the patient reported worsening pain.The patient underwent a revision surgery during which the shaft of the fractured screw was not able to be retrieved and the surgeon chose to leave the shaft in the bone.There were no additional patient impacts reported.
 
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Brand Name
POLARIS TRANSLATION SCREW, UNKNOWN SIZE
Type of Device
POLARIS SPINAL SYSTEM -TRANSLATION SCREW
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key10356793
MDR Text Key201379982
Report Number3012447612-2020-00405
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
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number14-5785XX
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) Death; Hospitalization; Other; Required Intervention;
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