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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. POLYAXIAL SCREW (DIA. 5.0 MM X 25 MM L); VIRAGE OCT SPINAL FIXATION SYSTEM
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ZIMMER BIOMET SPINE INC. POLYAXIAL SCREW (DIA. 5.0 MM X 25 MM L); VIRAGE OCT SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 07.01708.011
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/13/2020
Event Type  malfunction  
Manufacturer Narrative
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 that the first thread of the tulip on a polyaxial screw stripped while the surgeon was installing the closure top into place.The screw was removed and replaced to complete the procedure.There were no reported patient impacts.
 
Event Description
It was reported that the first thread of the tulip on a polyaxial screw stripped while the surgeon was installing the closure top into place.The screw was removed and replaced to complete the procedure.There were no reported patient impacts.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information and initially corrected information.Summary the complaint is confirmed for one (1) of one (1) returned virage screw (pn 07.01708.011) for the failure of fractured threads.Inspection the returned product matches information listed in the complaint file.Visual inspection of the product confirms that the top thread of the tulip has stripped.The complaint is confirmed.Dhr review the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.Potential root cause a definitive root cause cannot be determined with the information provided.It is possible that an off-axis force was used when attempting to install the closure top, resulting in the screw threads stripping.A follow-up report will be submitted if new information is received that changes the information provided in this report.
 
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Brand Name
POLYAXIAL SCREW (DIA. 5.0 MM X 25 MM L)
Type of Device
VIRAGE OCT SPINAL FIXATION SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key10830241
MDR Text Key215964776
Report Number3012447612-2020-00649
Device Sequence Number1
Product Code KWP
UDI-Device Identifier00889024328280
UDI-Public(01)00889024328280(10)AAL
Combination Product (y/n)N
PMA/PMN Number
K133556
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number07.01708.011
Device Lot NumberAAL
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2020
Was the Report Sent to FDA? No
Date Manufacturer Received02/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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