MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. POLARIS MULTI-AXIAL SCREW, SIZE UNKNOWN; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

Catalog Number SEE H10

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Possible catalog numbers: 2000-2445, 2000-2450, 2000-2540, or 2000-7450.Possible lot numbers: j3202578, j2991193, j3199541, j3193075 or j2631150.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 revision surgery was performed to address pain and a screw that fractured post-operatively in the l5/s1 area.

Manufacturer Narrative

D4: udi number: (b)(4).H4: dec 13, 2013, mar 12, 2013, dec 2, 2013, dec 13, 2013, or mar 7, 2012.Device evaluation: product was not returned.The x-ray provided does not clearly show the fracture.The complaint is unrefuted.Potential cause: root cause was unable to be determined.This event could possibly be attributed to unknown surgical, trauma or patient factors.Dhr review: per dhr review, the parts were likely conforming when they left zimvie control.No actions required.Device use: these devices are used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.

Event Description

It was reported that a revision surgery was performed to address pain and a screw that fractured post-operatively in the l5/s1 area.

• Brand Name: POLARIS MULTI-AXIAL 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: 15849069
• MDR Text Key: 304173200
• Report Number: 3012447612-2022-00274
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K061441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SEE H10
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2023
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female