MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 6.5 X 50MM MULTIAXIAL SCREW; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

Catalog Number 2000-2450

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 01/30/2020

Event Type  Injury  

Manufacturer Narrative

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.Reference reports 3012447612-2020-00140 to 3012447612-2020-00149.

Event Description

It was reported that during a spondylolisthesis correction procedure, the tulip heads shifted allowing the rods to bend towards the vertebrae rather than the vertebrae shifting to the location of the rod.The correction of the deformity was ineffective, the implants were tightened and left in place to complete the case.There were no reported additional patient impacts and no revision is scheduled at this time.This is report one of ten.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D11: catalog#: 2000-2450 pol 5.5 ti 6.5x50mm ma screw lot#: ni qty: 3; catalog#: 2000-1008 pol 5.5 ti derotation plug lot#: ni qty: 4; catalog#: 2000-5150 pol 5.5 ti 50mm ti curved rod 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.

Event Description

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

• Brand Name: 6.5 X 50MM MULTIAXIAL SCREW
• Type of Device: EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 9770701
• MDR Text Key: 182702421
• Report Number: 3012447612-2020-00140
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• PMA/PMN Number: K061441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2000-2450
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 70