MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. POLYAXIAL SCREW (DIA. 4.5 MM X 45 MM L); VIRAGE OCT SPINAL FIXATION SYSTEM

Catalog Number 07.01708.007

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

Udi number: ni.Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Event Description

It was reported that the threads of a pedicle screw tulip were damaged while the mating closure top was being installed.The screw was removed and replaced with an alternative screw to complete the procedure without reported patient impacts.

Manufacturer Narrative

Additional information in udi number, and method, results, and conclusions codes.The returned screw was examined.The threads of the tulip head were found to be stripped.The cause of this failure can be attributed to the threads not being correctly lined up during the application of the repeated forces during surgery.The cross-threading would subsequently cause the thread to strip.A review of the dhr did not identify any issues which would have contributed to this event.

Event Description

It was reported that the threads of a pedicle screw tulip were damaged while the mating closure top was being installed.The screw was removed and replaced with an alternative screw to complete the procedure without reported patient impacts.

• Brand Name: POLYAXIAL SCREW (DIA. 4.5 MM X 45 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 Key: 8745286
• MDR Text Key: 149546781
• Report Number: 3012447612-2019-00283
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• PMA/PMN Number: K133556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.01708.007
• Device Lot Number: AAC
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1