MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 7.5MM X 50MM MULTIAXIAL ILIAC SCREW; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

Catalog Number 14-500308

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2019

Event Type  malfunction  

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 during the procedure the screw lost polyaxial motion before the surgeon was able to lock in the rod.There was no additional surgical information provided and no reported patient impacts.

Manufacturer Narrative

The returned device was evaluated.Visual inspection revealed no signs of damage.A functional test was performed to see if the tulip had polyaxial motion on the screw.It was found that the tulip head is frozen, doesn't move at all.The complaint is confirmed.A review of the manufacturing records did not identify any issues related to this failure which would have contributed with this event.It is likely that possible that the damage to this screw head occurred during the attempted screw insertion and led the device to bind up.

Event Description

It was reported that during the procedure the screw lost polyaxial motion before the surgeon was able to lock in the rod.There was no additional surgical information provided and no reported patient impacts.

• Brand Name: 7.5MM X 50MM MULTIAXIAL ILIAC 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: 9573396
• MDR Text Key: 175240772
• Report Number: 3012447612-2020-00020
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-500308
• Device Lot Number: J6027812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1