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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. TOP LOADING POLY REDUCTION SCREW ASSEMBLIES 6.5X45MM VITALITY SPINAL FIXATION SYSTEM

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ZIMMER BIOMET SPINE INC. TOP LOADING POLY REDUCTION SCREW ASSEMBLIES 6.5X45MM VITALITY SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 07.02001.075
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 12/02/2020
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. Reference reports 3012447612-2020-00689, 3012447612-2020-00690, 3012447612-2020-00706, and 3012447612-2020-00707.

 
Event Description

It was reported there was a revision surgery to address patient pain associated with two closure tops that migrated out of their mating screws at l5 discovered five weeks post-op. The surgeon removed the two closure tops and the two corresponding pedicle screws. The surgeon replaced the screws with longer ones and replaced the closure tops. This is report four of four for this event.

 
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Brand NameTOP LOADING POLY REDUCTION SCREW ASSEMBLIES 6.5X45MM
Type of DeviceVITALITY SPINAL FIXATION SYSTEM
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
kim martinez
10225 westmoor dr.
na
westminster, CO 80021
3035144809
MDR Report Key11088996
MDR Text Key224275288
Report Number3012447612-2020-00707
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeSZ
PMA/PMN NumberK150896
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/29/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number07.02001.075
Device LOT NumberT09967
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/19/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/23/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/07/2018
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: 12/29/2020 Patient Sequence Number: 1
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