MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. POLARIS PEDICLE SCREW, UNKNOWN SIZE

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 11/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).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.

Event Description

It was reported that a pedicle screw shaft was found broken on post-operative x-rays.A revision surgery is planned to address the broken screw.

Manufacturer Narrative

The device was not returned for evaluation and the manufacturing records could not be reviewed since the part and lot numbers are unknown.However, a photo of a radiographic image was provided and reviewed, and shows the screw shaft has fractured about halfway down the length of the shaft within the vertebral body.The cause could not be determined from this image.The labeling was reviewed and found to contain warnings and lists implant fracture as a possible adverse effect.

• Brand Name: POLARIS PEDICLE SCREW, UNKNOWN SIZE
• Type of Device: PEDICLE SCREW
• 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: geoffrey gannon ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 7153016
• MDR Text Key: 96004505
• Report Number: 3012447612-2017-00712
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR