MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5 TI 6.5X45MM CANNULATED TRANSLATION SCREW; POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM

Catalog Number	14-571445C
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional 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.Reference report 3012447612-2020-00683.
Event or Problem Description
It was reported that the threads of one plug were damaged and the tulip of a pedicle screw was splayed/bent during installation in surgery.They were removed and replaced with another screw and plug to complete the procedure.There were no reported patient impacts.This is report one of two for this event.
Additional Manufacturer Narrative
A device evaluation was unable to be performed since the screw was not returned and no photos were provided.Potential cause: since the products were not returned, the root cause can't be established.Dhr review and related actions per the dhr review, the parts were likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use: this devices are used for treatment.Reported event is not related to a combination of product lines; therefore a compatibility review is not applicable.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 or Problem Description
It was reported that the threads of one plug were damaged and the tulip of a pedicle screw was splayed/bent during installation in surgery.They were removed and replaced with another screw and plug to complete the procedure.There were no reported patient impacts.This is report one of two for this event.

• Brand Name: 5.5 TI 6.5X45MM CANNULATED TRANSLATION SCREW
• Common Device Name: 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: 10971290
• Report Number: 3012447612-2020-00682
• Device Sequence Number: 4330115
• Product Code: NKB
• UDI-Device Identifier: 00880304949003
• UDI-Public: (01)00880304949003(10)2632811
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K123549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 14-571445C
• Device Lot Number: 2632811
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1