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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SEE H10; POLARIS SPINAL SYSTEM -TRANSLATION SCREW

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ZIMMER BIOMET SPINE INC. SEE H10; POLARIS SPINAL SYSTEM -TRANSLATION SCREW Back to Search Results
Catalog Number 14-578690 OR 14-578699
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Brand name: 5.5 ti 8.5x90mm translation screw or 5.5 ti 8.5x100mm translation screw.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 report 3012447612-2019-00301.
 
Event Description
It was reported that radiographic images detected a fractured iliac screw and rod during a follow-up visit.No further details have been provided.This is report one of two for this event.
 
Event Description
It was reported that radiographic images detected a fractured iliac screw and rod during a follow-up visit.No further details have been provided.This is report one of two for this event.
 
Manufacturer Narrative
The device was not returned for evaluation.However, x-rays were provided and used for evaluation.The x-rays show that there is a clear break in one iliac screw.The lot number is unknown so the manufacturing records were unable to be reviewed.The patient's weight, activity level, and bone quality information was not provided so it is difficult to tell if these factors may have influenced any non-fusion.Additionally, it is unknown if the patient experienced a traumatic event (such as a fall) that may have further contributed to the fracture seen.
 
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Brand Name
SEE H10
Type of Device
POLARIS SPINAL SYSTEM -TRANSLATION SCREW
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key8772883
MDR Text Key150843645
Report Number3012447612-2019-00300
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 company representative,health
Type of Report Initial,Followup
Report Date 01/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number14-578690 OR 14-578699
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/13/2019
Initial Date FDA Received07/09/2019
Supplement Dates Manufacturer Received12/23/2019
Supplement Dates FDA Received01/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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