MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. POLYAXIAL REDUCTION SCREW, DIA. 6.5MM X 45MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 703M6545

Device Problems Improper or Incorrect Procedure or Method (2017); Loosening of Implant Not Related to Bone-Ingrowth (4002)

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

Event Date 08/17/2023

Event Type  malfunction  

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 seventeen of eighteen for this event.

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.

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 seventeen of eighteen for this event.

Manufacturer Narrative

H6 additional investigation type codes: 4109 and 4110.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: product was not returned and no photos were provided.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: dhr review unable to be performed as lot information is not known.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.

• Brand Name: POLYAXIAL REDUCTION SCREW, DIA. 6.5MM X 45MM
• 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: 17765533
• MDR Text Key: 323623716
• Report Number: 3012447612-2023-00292
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183550
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 703M6545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 16 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic