MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. MULTIAXIAL ILIAC SCREW, SIZE UNKNOWN; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

Catalog Number 14-500XXX

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  malfunction  

Event Description

It was reported that the tip of a polaris 5.5 dorsal height adjuster stripped intra-operatively when removing a previously implanted iliac screw.The screw was unable to be removed.The reason the screw was being removed is not known.This is report one of two for this event.

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 report 3012447612-2022-00315.

Event Description

It was reported that the tip of a polaris 5.5 dorsal height adjuster stripped intra-operatively when removing a previously implanted iliac screw.The screw was unable to be removed.The reason the screw was being removed is not known.This is report one of two for this event.

Manufacturer Narrative

Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the screw was not returned and no photos were provided, so an evaluation was unable to be performed.Root cause: a definitive root cause cannot be determined with the information provided.The positioning of the screw or fusion around the screw may have contributed to the difficulty in removing it.Dhr review: the lot # for the screw was not provided, so the dhr was unable to be reviewed.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: MULTIAXIAL ILIAC SCREW, SIZE UNKNOWN
• 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: 16023629
• MDR Text Key: 306235278
• Report Number: 3012447612-2022-00314
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-500XXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2023
• 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