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	Failure of Implant (1924)
Date of Event	05/22/2023
Type of Reportable Event	Serious Injury
Additional 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 reports 3012447612-2023-00197 through 3012447612-2023-00198.
Event or Problem Description
It was reported that 12 days after surgery, the patient heard a noise from the implants and an x-ray found that the closure top and rod had migrated out of the pedicle screw on the left side of l5.A revision surgery was performed to remove the pedicle screw, rod, and closure top and replace them with another pedicle screw, rod, and closure top.There were no injuries that occurred during the revision surgery.This is report three of three for this event.
Event or Problem Description
It was reported that 12 days after surgery, the patient heard a noise from the implants and an x-ray found that the closure top and rod had migrated out of the pedicle screw on the left side of l5.A revision surgery was performed to remove the pedicle screw, rod, and closure top and replace them with another pedicle screw, rod, and closure top.There were no injuries that occurred during the revision surgery.This is report three of three for this event.
Additional Manufacturer Narrative
H6: additional method codes: 4109 and 4110.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed no clear damage to the device and all the threads were intact.X-rays were provided showing that the closure top and rod backed out of the pedicle 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: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge medical¿s 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: sabrina abla ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 17133823
• Report Number: 3012447612-2023-00199
• Device Sequence Number: 12609614
• Product Code: NKB
• UDI-Device Identifier: 00887868513831
• UDI-Public: (01)00887868513831(10)SBM141992
• 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: 2023
• 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): 06/17/2024

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: SBM141992
• 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: 05/29/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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 Age: 21 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic