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 Mechanical Jam (2983)

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

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

Udi number: ni.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 of a pedicle screw lost its polyaxial motion during surgery.An alternative screw was used to complete the procedure without reported patient impacts.

Manufacturer Narrative

The returned screw was examined.The tulip head was found to have non-smooth poly axial motion and damage to the hex; however the screw's motion was still functional.The cause of this event can likely be attributed to damage to the screw head during insertion leading to the device binding up.A review of the dhr did not find any issues which would have contributed to this event.

Event Description

It was reported that the tulip of a pedicle screw lost its polyaxial motion during surgery.An alternative screw was used to complete the procedure without reported patient impacts.

• 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
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: ashley mcpherson ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 8480669
• MDR Text Key: 140881542
• Report Number: 3012447612-2019-00161
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K061441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 2000-2450
• Device Lot Number: J3924393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 08/07/2019
• Supplement Dates FDA Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2017
• 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