MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5 TI 7.5X40MM CANNULATED TRANSLATION SCREW; POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM

Catalog Number 14-571540C

Device Problem Compatibility Problem (2960)

Patient Problem No Code Available (3191)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference reports 3012447612-2020-00001 to 3012447612-2020-00008 and 3012447612-2020-00008 to 3012447612-2020-00012.

Event Description

It was reported that during the procedure three pedicle screws were implanted and removed after eight set screws were stripped in the pedicle screw tulip heads.Alternate implants were used to complete the case.There was a greater than 30 minute delay but no reported patient impacts.This is report eleven of eleven.

Event Description

It was reported that during the procedure three pedicle screws were implanted and removed after eight set screws were stripped in the pedicle screw tulip heads.Alternate implants were used to complete the case.There was a greater than 30 minute delay but no reported patient impacts.This is report eleven of eleven.

Manufacturer Narrative

A visual inspection was conducted and found signs of use but no abnormal damage.A functional test found no issues since the device demonstrated full motion.Due to the functional test results, this complaint is unconfirmed.A review of the manufacturing records did not identify any issues related to this failure which would have contributed with this event.A definitive root cause cannot be determined.

• Brand Name: 5.5 TI 7.5X40MM CANNULATED TRANSLATION SCREW
• Type of Device: POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 9579338
• MDR Text Key: 174656374
• Report Number: 3012447612-2020-00012
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K123549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-571540C
• Device Lot Number: 2632851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other