MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5 HA MULTI SCREW 6.5 X 45MM; POLARIS SPINAL SYSTEM - HA COATED

Catalog Number 14-592445

Device Problem Break (1069)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 06/05/2019

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 four screws were found to have broken post operatively.The patient underwent revision surgery where the head of the screws were able to be removed but the shafts remained in the patient.No additional patient impact was reported.This is report one of four.

Manufacturer Narrative

Additional information: (udi number), and (method, results, and conclusions) - the returned screws were evaluated and confirmed to have fractured.The cause is unable to be determined.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.

Event Description

It was reported that four screws were found to have broken post operatively.The patient underwent revision surgery where the head of the screws were able to be removed but the shafts remained in the patient.No additional patient impact was reported.This is report one of four.

• Brand Name: 5.5 HA MULTI SCREW 6.5 X 45MM
• 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 mcpherson ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 8957842
• MDR Text Key: 156350418
• Report Number: 3012447612-2019-00363
• Device Sequence Number: 1
• Product Code: NKB
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-592445
• Device Lot Number: 2615891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2018
• 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