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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CLOSURE TOP; VITALITY SPINAL FIXATION SYSTEM
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ZIMMER BIOMET SPINE INC. CLOSURE TOP; VITALITY SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 07.02010.001
Device Problems Noise, Audible (3273); Migration (4003)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 report (b)(4).
 
Event Description
It was reported that a closure top was found to have migrated postoperatively.The patient reports hearing a squeaking noise as she walked but reports no additional impacts.There are no plans to revise at this time.This is report one of two for this event.
 
Event Description
It was reported that a closure top was found to have migrated postoperatively.The patient reports hearing a squeaking noise as she walked but reports no additional impacts.There are no plans to revise at this time.This is report one of two for this event.
 
Manufacturer Narrative
Additional information in h6: method, results, and conclusions.The product was not returned.However, x-ray images were provided.These images show that the closure tops have migrated out of the l5 screws at the top of the construct.An internal capa was initiated to evaluate the cause of this issue.This investigation found that the vital mis extended tab screw housing and tab designs were more susceptible to conditions that could result in inadequate locking, such as splaying, thread movement, and reduction based issues.The screws are the subject of field action 3012447612-05-01-2020-001-r; however, this closure top is not within the scope of the field action.The lot number was not provided, so the dhr is unable to be reviewed.The labeling was reviewed does not appear to have contributed to this event.
 
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Brand Name
CLOSURE TOP
Type of Device
VITALITY SPINAL FIXATION SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key10028601
MDR Text Key189997403
Report Number3012447612-2020-00277
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 health professional
Type of Report Initial,Followup
Report Date 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number07.02010.001
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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