MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SEE H10; POLARIS SPINAL SYSTEM -TRANSLATION SCREW

Catalog Number 14-578690 OR 14-578699

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Brand name: 5.5 ti 8.5x90mm translation screw or 5.5 ti 8.5x100mm translation screw.Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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.Reference report 3012447612-2019-00301.

Event Description

It was reported that radiographic images detected a fractured iliac screw and rod during a follow-up visit.No further details have been provided.This is report one of two for this event.

Event Description

It was reported that radiographic images detected a fractured iliac screw and rod during a follow-up visit.No further details have been provided.This is report one of two for this event.

Manufacturer Narrative

The device was not returned for evaluation.However, x-rays were provided and used for evaluation.The x-rays show that there is a clear break in one iliac screw.The lot number is unknown so the manufacturing records were unable to be reviewed.The patient's weight, activity level, and bone quality information was not provided so it is difficult to tell if these factors may have influenced any non-fusion.Additionally, it is unknown if the patient experienced a traumatic event (such as a fall) that may have further contributed to the fracture seen.

• Brand Name: SEE H10
• Type of Device: POLARIS SPINAL SYSTEM -TRANSLATION SCREW
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 8772883
• MDR Text Key: 150843645
• Report Number: 3012447612-2019-00300
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K140123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-578690 OR 14-578699
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 12/23/2019
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1