MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. VITAL MIS POLYAXIAL SCREW 6.5X45MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number	824M6545
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
Additional 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.Reference report 3012447612-2023-00114.
Event or Problem Description
It was reported that a closure top was found to have migrated out of the mating vital mis screw via x-ray taken at the patient's one month postoperative appointment.A revision surgery is scheduled to remove and remove and replace the screw and closure top.This is report two of two for this event.
Event or Problem Description
It was reported that a closure top was found to have migrated out of the mating vital mis screw via x-ray taken at the patient's one month postoperative appointment.A revision surgery was performed to remove and replace the screw and closure top.The revision surgery was a success without any issues.This is report two of two for this event.
Additional Manufacturer Narrative
Corrections in d4: lot & udi number, d9, and h3.Additional information in b5, h4, and h6: component, investigation type, findings, and conclusions.Device evaluation: visual inspection of the returned device revealed signs of use, but no signs of any damage.A functional inspection was performed with the returned screw (pn 824m6545 lot sbm141994) and found the closure top was able to mate with the screw and fully seat into the tulip head.Review of the provided x-ray images shows that the closure top has clearly migrated out of the screw.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown patient or surgical factors.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.

• Brand Name: VITAL MIS POLYAXIAL SCREW 6.5X45MM
• Common Device Name: 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: 16746929
• Report Number: 3012447612-2023-00115
• Device Sequence Number: 11579402
• Product Code: NKB
• UDI-Device Identifier: 00887868513831
• UDI-Public: (01)00887868513831(10)SBM141994
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203507
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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
• Operator of Device: Other
• Device Catalogue Number: 824M6545
• Device Lot Number: SBM141994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic