MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. POLYAXIAL SCREW, DIA. 5.5MM X 35MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number	701M5535
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/07/2022
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.
Event or Problem Description
It was reported that a revision surgery was performed where a vital pedicle screw was removed due to loosening and pseudarthrosis; it is believed to have been replaced by competitive products.After the initial surgery, the surgeon confirmed the appearance of cyst-like lesions above and below the cage with ct images, and the patient experienced pain.It is unclear if this was the cause, but it resulted in inadequate bone union and one screw loosened.
Additional Manufacturer Narrative
Information was erroneously entered into h3; there are no changes from the initial report.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: product was not returned, however x-rays were provided.The complaint is confirmed.Root cause: root cause was unable to be determined.This event could possibly be attributed to unknown operational or patient factors.It could also be attributed to the lesions described by the complainant.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.
Event or Problem Description
It was reported that a revision surgery was performed where a vital pedicle screw was removed due to loosening and pseudarthrosis; it is believed to have been replaced by competitive products.After the initial surgery, the surgeon confirmed the appearance of cyst-like lesions above and below the cage with ct images, and the patient experienced pain.It is unclear if this was the cause, but it resulted in inadequate bone union and one screw loosened.

• Brand Name: POLYAXIAL SCREW, DIA. 5.5MM X 35MM
• 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: 13996414
• Report Number: 3012447612-2022-00078
• Device Sequence Number: 4433032
• Product Code: NKB
• UDI-Device Identifier: 00880304867079
• UDI-Public: (01)00880304867079(10)T10219
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 701M5535
• Device Lot Number: T10219
• Was Device Available for Evaluation?: No
• 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: 03/07/2022
• Supplement Date Received by Manufacturer: 07/17/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female