MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5 HA MULTI SCREW 7.5 X 40MM; POLARIS SPINAL SYSTEM - HA COATED

Catalog Number 14-592540

Device Problems Fracture (1260); Noise, Audible (3273)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 01/22/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation but photos of the device were provided.The screw appears fractured in a manner consistent with a fatigue fracture.The complaint is confirmed.A review of the manufacturing records did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain instructions regarding proper device usage.Reference report 3012447612-2020-00313.

Event Description

It was reported that a patient underwent a revision surgery after two polaris screws were found to have fractured postoperatively at s1.The patient reported increasing back pain, left leg radiculopathy and a creaking sound from the implants prior to the revision.The fractured portion of the screw was removed but the shaft was retained by the patient.The level was reinstrumented after the surgeon found no fusion present.The patient reports ongoing back pain after the revision.This is report two of two for this event.

• Brand Name: 5.5 HA MULTI SCREW 7.5 X 40MM
• Type of Device: POLARIS SPINAL SYSTEM - HA COATED
• 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 krieger ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 10330044
• MDR Text Key: 200594928
• Report Number: 3012447612-2020-00338
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00888480594277
• UDI-Public: (01)00888480594277(10)2611681
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141804
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2020

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: 14-592540
• Device Lot Number: 2611681
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2017
• 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): Hospitalization; Other; Required Intervention
• Patient Weight: 73