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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5 TI 7.5X55MM TRANSLATION SCREW POLARIS SPINAL SYSTEM -TRANSLATION SCREW

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ZIMMER BIOMET SPINE INC. 5.5 TI 7.5X55MM TRANSLATION SCREW POLARIS SPINAL SYSTEM -TRANSLATION SCREW Back to Search Results
Catalog Number 14-578555
Device Problems Fracture (1260); Difficult to Insert (1316)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/20/2019
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 3012447612-2019-00556 to 3012447612-2019-00558 and 3012447612-2019-00566.

 
Event Description

It was reported that during the procedure, while attempting to screw into extremely hard bone, the screw stopped advancing. The surgeon attempted to put the driver in reverse and back out the screw but the tip of the driver sheared off. The surgeon tried a second driver whose tip also sheared off and a dorsal height adjuster that broke. The surgeon was unable to advance or remove the screw, so he cut off the top of screw and left half of the screw shaft embedded within the bone. A screw was unable to be placed on this side at this level of the construct. There were no reported impacts associated with the screw shaft. This is report four of four for this event.

 
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Brand Name5.5 TI 7.5X55MM 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 Key9506992
MDR Text Key172393708
Report Number3012447612-2019-00566
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK140123
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 09/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/20/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number14-578555
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/30/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 12/20/2019 Patient Sequence Number: 1
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