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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

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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 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
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 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. A sales rep reported that he missed a screw on the original report. There were a total of five screws. This report is the fifth report of the previously four reported for this event.
 
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Brand Name5.5 TI 6.5X45MM 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 mcpherson
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key9365858
MDR Text Key167766005
Report Number3012447612-2019-00433
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
Type of Report Initial,Followup
Report Date 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number14-578445
Device Lot Number2558041
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/22/2019 Patient Sequence Number: 1
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