MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5 TI 5.5X40MM TRANSLATION SCREW; POLARIS SPINAL SYSTEM -TRANSLATION SCREW

Catalog Number 14-578340

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 07/23/2020

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 a patient underwent a revision for polaris screw disassembly that was a cobalt chrome rod case.

Event Description

It was reported that some polaris translation screws disassembled post-op; an spf bone stimulator was installed along with the screws.This is 1 of 8 reports for this event.

Manufacturer Narrative

Additional information on b3, b5, d7, e1.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

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D11: catalog#: 14-578340 pol trans 5.5 ti 5.5x40mm trns lot#: ni qty: 5.Catalog#: 14-578445 pol trans 5.5 ti 6.5x45mm trns lot#: ni qty: 2.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

Corrected information in h6: findings and h9.Information added to h6: component codes and h7.This follow-up report is being submitted to relay additional information.Products were not returned and no photos were provided, so a device evaluation cannot be performed.Similar events found fractured trolleys, due to reaction with spf, allowing the screws to disassemble in-vivo.The associated ifu was updated and the user was notified.An internal capa is investigating the cause.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Event Description

It was reported that some polaris translation screws disassembled post-op; an spf bone stimulator was installed along with the screws.This is 1 of 8 reports for this event.

• Brand Name: 5.5 TI 5.5X40MM TRANSLATION SCREW
• Type of Device: POLARIS SPINAL SYSTEM -TRANSLATION SCREW
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10443041
• MDR Text Key: 204037562
• Report Number: 3012447612-2020-00485
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K140123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-578340
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0570-2021
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR