MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5 TI 6.5X50MM TRANSLATION SCREW; POLARIS SPINAL SYSTEM -TRANSLATION SCREW

Catalog Number 14-578450

Device Problem Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 12/04/2017

Event Type  Injury  

Manufacturer Narrative

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 the tulip head splayed while placing a set screw during surgery.The screw was removed and replaced with an alternative screw.There was a surgical delay greater than 30 minutes associated with this event.There were no patient impacts reported as a result of the delay.

Manufacturer Narrative

The returned screw was evaluated.Visual inspection revealed that the tulip head is splayed.It is likely that the alignment block on the inserter was forced too far into the tulip head causing the tulip to splay and ultimately become stuck to the inserter.A review of the dhr did not identify any issues which may have contributed to this event.

• Brand Name: 5.5 TI 6.5X50MM TRANSLATION SCREW
• Type of Device: POLARIS SPINAL SYSTEM -TRANSLATION 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: 7152957
• MDR Text Key: 96002842
• Report Number: 3012447612-2017-00711
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PK140123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

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
• Device Catalogue Number: 14-578450
• Device Lot Number: 2430591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2014
• 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