MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 6.5 X 40MM MULTIAXIAL REDUCTION SCREW; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

Catalog Number 2000-7440

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 09/25/2018

Event Type  Injury  

Manufacturer Narrative

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 3012447612-2018-00861 thru 3012447612-2018-00872.

Event Description

It was reported that two screws were found to have disassembled and one plug had migrated out of a third screw post-operatively.A revision surgery was performed to remove and replace the screws and plug.During the revision, eight plugs were found to have loosened from their mating pedicle screws.These plugs were also removed and replaced.This is report eleven of twelve for this event.

Manufacturer Narrative

Additional information: catalog number and lot number; 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 two screws were found to have disassembled and one plug had migrated out of a third screw post-operatively.A revision surgery was performed to remove and replace the screws and plug.During the revision, eight plugs were found to have loosened from their mating pedicle screws.These plugs were also removed and replaced.This is report eleven of twelve for this event.

Manufacturer Narrative

Udi number: na.Additional information: method, results and conclusion - the returned screw was examined.The tulip head had lost polyaxial motion and was found to be fixed in position.When final tightening occurs, it also locks the tulip head in place to prevent movement post-operatively and keep the construct rigid.Due to deformation during the final tightening process, the tulip head can remain fixed after the plug is removed.As the device is intended for one-time use, this does not affect its intended function.There is no visual evidence that indicates this screw contributed to the plug backing out.Plug back out can result from inadequate plug positioning.The patient's scoliosis may have contributed to the inadequate plug positioning as this would likely have made the procedure more difficult.There were no manufacturing issues detected which would have contributed to this event.

Event Description

It was reported that two screws were found to have disassembled and one plug had migrated out of a third screw post-operatively.A revision surgery was performed to remove and replace the screws and plug.During the revision, eight plugs were found to have loosened from their mating pedicle screws.These plugs were also removed and replaced.This is report eleven of twelve for this event.

• Brand Name: 6.5 X 40MM MULTIAXIAL REDUCTION SCREW
• Type of Device: EBI 5.5 HELICAL FLANGE SPINAL 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: ashley mcpherson ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 8022581
• MDR Text Key: 125590180
• Report Number: 3012447612-2018-00871
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K061441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2000-7440
• Device Lot Number: 2076511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 10/31/2018
• Supplement Dates Manufacturer Received: 02/18/2019; 03/28/2019
• Supplement Dates FDA Received: 03/19/2019; 03/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2007
• 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): Hospitalization; Required Intervention
• Patient Age: 17 YR