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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SEE H10; VITALITY SPINAL FIXATION SYSTEM
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ZIMMER BIOMET SPINE INC. SEE H10; VITALITY SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number SEE H10
Device Problems Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Cannulated polyaxial extended tab screw 7.5x45mm or cannulated polyaxial extended tab screw 6.5x50mm.Catalog number: 810m6550 or 810m7545.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 3012447612-2020-00277.
 
Event Description
It was reported that a closure top was found to have migrated postoperatively.The patient reports hearing a squeaking noise as she walks but reports no additional impacts.There are no plans to revise at this time.This is report two of two for this event.
 
Manufacturer Narrative
H9: 3012447612-05-01-2020-001-r the screw was not returned, however x-rays were provided which showed the mating closure top migrated out of the screw.An internal capa found the cause is related to 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 dhr was unable to be reviewed since the device identity is unknown.The labeling was reviewed and found to contain instructions regarding proper device installation.This screw is within the scope of recall 3012447612-05-01-2020-001-r.
 
Event Description
It was reported that a closure top was found to have migrated postoperatively.The patient reports hearing a squeaking noise as she walks but reports no additional impacts.There are no plans to revise at this time.This is report two of two for this event.
 
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Brand Name
SEE H10
Type of Device
VITALITY SPINAL FIXATION SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key10028608
MDR Text Key189995276
Report Number3012447612-2020-00278
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K183550
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Recall
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 NumberSEE H10
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberSEE H10
Patient Sequence Number1
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