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
Medical Device Problem Codes	Fracture (1260); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	01/22/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: POLARIS SPINAL SYSTEM - HA COATED
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10330044
• Report Number: 3012447612-2020-00338
• Device Sequence Number: 3427066
• Product Code: NKB
• UDI-Device Identifier: 00888480594277
• UDI-Public: (01)00888480594277(10)2611681
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K141804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 14-592540
• Device Lot Number: 2611681
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Weight: 73