MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD POLARIS 5.5 TI 6.5X50MM MULTIAXIAL SCREW

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/14/2015

Event Type  Injury  

Manufacturer Narrative

It is reported the hospital discarded the screws, therefore no product evaluation is able to be conducted on the explanted screws.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.Report three of three for the same event, see also 3004485144-2015-00096 and 00097.

Event Description

The sales associate reported the surgeon was using polaris 5.5 on (b)(6) 2015 in a lumbar case.He was using the specialty driver for the standard screws (2000-2445 x2 and 2000-2450 x2).The first two screws were implanted into the pedicle fine.While implanting the next screw he disengaged the driver from the screw and when he inserted the driver back in the same screw to tighten more, the driver was not fully seated into the screw properly, and the screw was inserted through the pedicle laterally, fracturing the vertebral body.The surgeon explanted all the screws and completed the surgery using a different system.

• Brand Name: POLARIS 5.5 TI 6.5X50MM MULTIAXIAL SCREW
• Type of Device: SCREW
• Manufacturer (Section D): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer (Section G): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer Contact: michelle cole ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 5246368
• MDR Text Key: 32022020
• Report Number: 3004485144-2015-00098
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK061441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 2000-2450
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2015
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other