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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CLOSURE TOP TORQUE LIMITING; VITALITY SPINAL FIXATION SYSTEM
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ZIMMER BIOMET SPINE INC. CLOSURE TOP TORQUE LIMITING; VITALITY SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 07.02010.001
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem No Code Available (3191)
Event Date 11/20/2018
Event Type  malfunction  
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 3012447612-2018-00989 thru 3012447612-2018-01002.
 
Event Description
It was reported that a revision surgery was performed to address five closure tops which migrated post-operatively.During the revision, an additional nine closure tops were found loose.The construct was removed and replaced with an alternative construct to complete the procedure.This is report thirteen of fourteen for this event.
 
Manufacturer Narrative
(b)(4).The device and x-rays were provided and used for evaluation.The devices were confirmed for post-op loosening/back-out via the x-ray.Witness marks on the bottom of the closure top were consistent with off-axis force of the driver due to improper seating of the rod which likely allowed the back-out that was seen.A review of the dhr did not find any issues which would have contributed to this event.
 
Event Description
It was reported that a revision surgery was performed to address five closure tops which migrated post-operatively.During the revision, an additional nine closure tops were found loose.The construct was removed and replaced with an alternative construct to complete the procedure.This is report thirteen of fourteen for this event.
 
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Brand Name
CLOSURE TOP TORQUE LIMITING
Type of Device
VITALITY 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
ashley mcpherson
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key8152916
MDR Text Key130040938
Report Number3012447612-2018-01001
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K150896
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number07.02010.001
Device Lot NumberP142410
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age37 YR
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