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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.
 
Manufacturer Narrative
Additional information: d4: lot number.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 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.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information and initially corrected information.Summary: the complaint is confirmed for both returned screw for not retaining the closure top post op, one of them is also confirmed to have damage on the tulip threads.No medical records were provided with the complaint.Inspection: the specified identity of the devices was confirmed and the devices were examined.Visual inspection revealed thread damage on the tulip threads of one of the returned screws (07.02001.075).There were no indications of damage on the second screw.Photos of x-rays were also provided for review.The x-rays showed that the closure tops have migrated.The complaint is confirmed.Dhr review: the dhrs were reviewed.There are no indications of manufacturing issues which would have contributed to this event and the devices were likely conforming when they left zimmer biomet¿s control.Potential root cause a definitive root cause cannot be determined with the information provided.During inspection of the returned parts it was found that there was thread damage on the tulip threads of one of the returned screws.There were no indications of manufacturing issues with the screw and there was no sign of damage on either of the returned closure tops, so the screw thread damage most likely happened during removal or at some point post-op after the closure top had migrated.A follow-up report will be submitted if new information is received that changes the information provided in this report.
 
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.
 
Manufacturer Narrative
An independent surgeon in the us reviewed the provided images and believes the cause is related to not having the rod seated/reduced fully down into the tulip of the pedicle screw when the closure top was final tightened because of the degree of the patient's spondylolisthesis, therefore preventing the closure tops from fully tightening in the pedicle screws and allowing for later migration.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
 
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 Name
TOP LOADING POLY REDUCTION SCREW ASSEMBLIES 6.5X45MM
Type of Device
VITALITY SPINAL FIXATION SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key11088996
MDR Text Key224275288
Report Number3012447612-2020-00707
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K150896
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
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
Was the Report Sent to FDA? No
Date Manufacturer Received06/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age34 YR
Patient Weight89
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