MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. VITAL MIS POLYAXIAL SCREW, UNKNOWN SIZE; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 824MXXXX

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Spinal Column Injury (2081)

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.Reference report 3012447612-2021-00433.

Event Description

It was reported that two pedicle screws pulled out of the bone intra-operatively, compromising the bone.The patient had very bone quality.No further information has been provided.This is report one of two for this event.

Manufacturer Narrative

Additional information in h6: component, investigation type, findings, and conclusions.Inspection: the product was not returned so an evaluation is unable to be performed.Dhr review: the lot numbers were not provided, so the dhrs were unable to be reviewed.Potential root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to poor patient bone quality or improper surgical technique.Further analysis could not be performed as lot numbers were not provided.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.

Event Description

It was reported that two pedicle screws pulled out of the bone intra-operatively, compromising the bone.The patient had very bone quality.No further information has been provided.This is report one of two for this event.

• Brand Name: VITAL MIS POLYAXIAL SCREW, UNKNOWN SIZE
• 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.; na; westminster CO 80021
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 12828519
• MDR Text Key: 280883981
• Report Number: 3012447612-2021-00432
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 824MXXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 03/15/2022
• Supplement Dates FDA Received: 03/19/2022
• 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 Outcome(s): Other