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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5 HA MULTI SCREW 6.5 X 50MM; POLARIS SPINAL SYSTEM - HA COATED
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ZIMMER BIOMET SPINE INC. 5.5 HA MULTI SCREW 6.5 X 50MM; POLARIS SPINAL SYSTEM - HA COATED Back to Search Results
Catalog Number 14-592450
Device Problem Break (1069)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Event Date 06/05/2019
Event Type  Injury  
Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.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 four screws were found to have broken post operatively.The patient underwent revision surgery where the head of the screws were able to be removed but the shafts remained in the patient.No additional patient impact was reported.This is report four of four.
 
Event Description
It was reported that four screws were found to have broken post operatively.The patient underwent revision surgery where the head of the screws were able to be removed but the shafts remained in the patient.No additional patient impact was reported.This is report four of four.
 
Manufacturer Narrative
The returned screws were evaluated.Fracture was observed and confirmed.Based on information from the complaint, the fracture can be attributed to the patient's condition.There were no other signs of damage on the device.The labeling was reviewed and found to contain instructions regarding proper device usage.
 
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Brand Name
5.5 HA MULTI SCREW 6.5 X 50MM
Type of Device
POLARIS SPINAL SYSTEM - HA COATED
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key8957898
MDR Text Key156388377
Report Number3012447612-2019-00366
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K141804
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number14-592450
Device Lot Number2436842
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/05/2019
Initial Date FDA Received09/03/2019
Supplement Dates Manufacturer Received01/23/2020
Supplement Dates FDA Received02/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
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