MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 8.5MM X 80MM MULTIAXIAL ILIAC SCREW; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

Catalog Number 14-500334

Device Problem Difficult to Remove (1528)

Patient Problems Ossification (1428); Foreign Body In Patient (2687)

Event Date 04/20/2022

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 3012447612-2022-00134 through 3012447612-2022-00136.

Event Description

It was reported that two polaris 5.5 iliac screws were unable to be removed during a removal surgery after fusion was complete; the screws were strongly attached to the bone.While attempting to remove the first screw, the tip of the height adjuster broke off and became stuck in the screw shaft, preventing the removal of either piece.The tulip detached from the screw shaft while removing the second screw, so it also was unable to be fully removed.The surgeon does not anticipate further actions and the patient is in good condition.This is report two of three for this event.

Event Description

It was reported that two polaris 5.5 iliac screws were unable to be removed during a removal surgery after fusion was complete; the screws were strongly attached to the bone.While attempting to remove the first screw, the tip of the height adjuster broke off and became stuck in the screw shaft, preventing the removal of either piece.The tulip detached from the screw shaft while removing the second screw, so it also was unable to be fully removed.The surgeon does not anticipate further actions and the patient is in good condition.This is report two of three for this event.

Manufacturer Narrative

Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: no photos were provided of the screws, so no device evaluation could be completed of the screws.Root cause: root cause was unable to be determined.This event could possibly be attributed to the bone growing around the screws and hardening to the point that the screw was unable to be removed.Dhr review: dhr review for the screws unable to be performed as lot number was not provided.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

• Brand Name: 8.5MM X 80MM MULTIAXIAL ILIAC 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: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 14463117
• MDR Text Key: 292350425
• Report Number: 3012447612-2022-00135
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-500334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male