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 Problems Material Twisted/Bent (2981); Positioning Problem (3009)

Patient Problem Pain (1994)

Event Date 08/17/2021

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 a revision was performed to remove a pedicle screw because a scan showed the screw had breached the pedicle wall.When the screw was removed, the shaft of the screw was very slightly bent.A new screw was placed during the revision.

Event Description

It was reported a revision was performed to remove a pedicle screw because a scan showed the screw had breached the pedicle wall.When the screw was removed, the shaft of the screw was very slightly bent.A new screw was placed during the revision.

Manufacturer Narrative

Device evaluation visual inspection revealed the screw shank is bent.The tulip head is also stuck in place.Potential cause a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to an off-axis force placed on the screw during the original surgery or the screw not being sized/positioned correctly during the original surgery.Dhr review per dhr review, the part was likely conforming when it left zimmer biomet control.Device use this device is used for treatment.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.

• 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: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 12463837
• MDR Text Key: 271267714
• Report Number: 3012447612-2021-00346
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00888480207764
• UDI-Public: (01)00888480207764(10)J6783199
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2000-2450
• Device Lot Number: J6783199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention