MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. BOTTOM LOADING POLY OPEN ILIAC SCREW ASSEMBLIES 9.5X90; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 07.02050.210

Device Problems Disassembly (1168); Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/03/2018

Event Type  Injury  

Manufacturer Narrative

The surgeon stated that the screw head started to hit the ilium as he was advancing the screw and this may have been a contributing factor to the screw becoming stuck within the patient's bone.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 reports 3012447612-2018-00456 thru 3012447612-2018-00459.

Event Description

It was reported that a pedicle screw was difficult to install during surgery and the tip of one driver broke while attempting to install the screw.Once the driver was removed, the tulip of the pedicle screw disassembled from the shaft.Two drivers started to shear while trying to remove the screw shaft, but the screw shaft could not be removed and remains implanted.There were no reported patient impacts outside of the remaining screw shaft.This is report one of four for this event.

Manufacturer Narrative

The product was not returned and no photos were provided, so an evaluation could not be performed.As such, no evaluation results are available and no conclusions regarding the cause can be drawn.The lot number was not provided, so the manufacturing records could not be reviewed.

Event Description

It was reported that a pedicle screw was difficult to install during surgery and the tip of one driver broke while attempting to install the screw.Once the driver was removed, the tulip of the pedicle screw disassembled from the shaft.Two drivers started to shear while trying to remove the screw shaft, but the screw shaft could not be removed and remains implanted.There were no reported patient impacts outside of the remaining screw shaft.This is report one of four for this event.

• Brand Name: BOTTOM LOADING POLY OPEN ILIAC SCREW ASSEMBLIES 9.5X90
• Type of Device: VITALITY SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: geoffrey gannon ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 7571858
• MDR Text Key: 110166715
• Report Number: 3012447612-2018-00456
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK150896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.02050.210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other