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

Without a product return, no product evaluation is able to be conducted.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.

Event Description

It was reported that a patient underwent a revision surgery after a screw, at s1, was found to have fractured postoperatively.The screw was removed and replaced with an alternate same size screw to complete the procedure.It was also reported that the patient retained a foreign body but, no further information was provided.

Manufacturer Narrative

H3 field entered in error.Correction to: d4 (lot number).Additional information in: a1, a4, b3, b5, b7, d4 (udi number), e1, e2, g3, h4, and h6 (patient codes, device codes, method, results, and conclusions).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 3012447612-2020-00338.

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 one 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
• MDR Report Key: 10141541
• MDR Text Key: 194754068
• Report Number: 3012447612-2020-00313
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K141804
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• 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
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Weight: 73