MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. POLYAXIAL SCREW (DIA. 5.0 MM X 25 MM L); VIRAGE OCT SPINAL FIXATION SYSTEM

Catalog Number	07.01708.011
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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.

• Brand Name: POLYAXIAL SCREW (DIA. 5.0 MM X 25 MM L)
• Common Device Name: VIRAGE OCT SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10830241
• Report Number: 3012447612-2020-00649
• Device Sequence Number: 19714440
• Product Code: KWP
• UDI-Device Identifier: 00889024328280
• UDI-Public: (01)00889024328280(10)AAL
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 07.01708.011
• Device Lot Number: AAL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1