MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. CLOSURE TOP; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 07.02010.001

Device Problems Improper or Incorrect Procedure or Method (2017); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2023

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Event Description

It was reported that a revision surgery was performed on a vital construct to address two closure tops that migrated out of two reduction screws, allowing the end of two rods to also migrate post-operatively.During the revision, six additional closure tops were found to be loose (but did not migrate) in their reduction screws.The closure tops were removed and replaced; the surgeon elected to use the existing reduction screws and rods.It was also reported that the surgeon did not use the reduction screw tab sleeve during the initial procedure; the use of the reduction screw tab sleeve is required during closure top insertion and provisional tightening when using reduction screws per the device labeling.This is report one of eighteen for this event.

Manufacturer Narrative

In h3, the selection "device evaluation anticipated, but not yet begun (02)" cannot be deleted and no longer applies.H6 additional investigation type codes: 4109 and 4110.Corrections in h3.Additional information in d4: udi number, h4, and h6: component, investigation type, findings, and conclusions.Device evaluation: product was returned and showed indications of use and removal.X-rays were provided and used to confirm the loosening of all closure tops & migration of two closure tops and the two rods.Root cause: root cause was unable to be determined.This event could possibly be attributed to unknown surgical, patient or traumatic factors.It is possible that the reduction tab sleeves were not used as stated in the event description.Without operational notes, however, that cannot be determined for certain.Dhr review: per dhr review, the part was likely conforming when it left zimvie control.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.Reference reports 3012447612-2023-00276 through 3012447612-2023-00293.

Event Description

It was reported that a revision surgery was performed on a vital construct to address two closure tops that migrated out of two reduction screws, allowing the end of two rods to also migrate post-operatively.During the revision, six additional closure tops were found to be loose (but did not migrate) in their reduction screws.The closure tops were removed and replaced; the surgeon elected to use the existing reduction screws and rods.It was also reported that the surgeon did not use the reduction screw tab sleeve during the initial procedure; the use of the reduction screw tab sleeve is required during closure top insertion and provisional tightening when using reduction screws per the device labeling.This is report one of eighteen for this event.

• Brand Name: CLOSURE TOP
• Type of Device: VITALITY SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 17765627
• MDR Text Key: 323626165
• Report Number: 3012447612-2023-00276
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150896
• Exemption Number: 5645646
• 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: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.02010.001
• Device Lot Number: W566811
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/29/2023
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2018
• 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
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic