MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. POLYAXIAL SCREW, Ø6.5MM X 40MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number	701M6540
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Rash (2033); Swelling (2091); Eczema (4547); Swelling/ Edema (4577)
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 numbers 3012447612-2020-00629 thru 3012447612-2020-00642.
Event or Problem Description
It was reported that the patient is having a possible allergic reaction to some spinal implants.The installed implants include an epic construct and a breckenridge cage.The patient is allergic to nickel and may be sensitive to cobalt chrome.Allergy tests are on-going and a plan for care has not yet been made.This is report eight of 14 for this event.
Event or Problem Description
It was reported that the patient is having a possible allergic reaction to some spinal implants.The installed implants include an epic construct and a breckenridge cage.The patient is allergic to nickel and may be sensitive to cobalt chrome.Allergy tests are on-going and a plan for care has not yet been made.This is report eight of 14 for this event.
Additional Manufacturer Narrative
Information added to d8 and h6: component, investigation type, findings, and conclusions.This follow-up report is being submitted to relay additional information.Summary: the complaint is unrefuted for the vitality construct causing an allergic reaction.Medical records were not provided for review.Device evaluation: product was not returned as it remains implanted.A device evaluation could not be performed.Potential cause: root cause was unable to be determined with the available information.Dhr review and related actions: the lot numbers were not provided, so the dhr review could not be performed.Device use: these devices are used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
Additional Manufacturer Narrative
Corrected information in b5.A follow-up report will be submitted if new information is received that changes the information provided in this report.
Event or Problem Description
It was reported that the patient is having a possible allergic reaction to some spinal implants.The installed implants include a pedicle screw construct.The patient is allergic to nickel and may be sensitive to cobalt chrome.Allergy tests are on-going and a plan for care has not yet been made.This is report eight of 14 for this event.
Additional Manufacturer Narrative
H6: additional patient code: 4421.Corrections in b5, b6, b7, d4: lot & udi numbers, h6: clinical and impact codes.Additional information in a2, a4, a5, a6, d6b, and h4.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 the patient is having a possible allergic reaction to some spinal implants, including tingling, swelling, and eczema.The installed implants include a pedicle screw construct.The patient is allergic to nickel and may be sensitive to cobalt chrome.Allergy tests are on-going.This is report 12 of 14 for this event.New information received: a revision surgery was performed to remove the posterior fusion construct.
Additional Manufacturer Narrative
H6: additional method code: 4110 additional information in h6: investigation type, findings, and conclusions.Device evaluation: the device was not returned and no photos were provided, so an evaluation is unable to be performed.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.
Event or Problem Description
It was reported that the patient is having a possible allergic reaction to some spinal implants, including tingling, swelling, and eczema.The installed implants include a pedicle screw construct.The patient is allergic to nickel and may be sensitive to cobalt chrome.Allergy tests are on-going.This is report 12 of 14 for this event.New information received: a revision surgery was performed to remove the posterior fusion construct.

• Brand Name: POLYAXIAL SCREW, Ø6.5MM X 40MM
• 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: jessica buzbee ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3038034523
• MDR Report Key: 10713246
• Report Number: 3012447612-2020-00636
• Device Sequence Number: 3899415
• Product Code: NKB
• UDI-Device Identifier: 00880304867505
• UDI-Public: (01)00880304867505(10)T09877
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171907
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/21/2025

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: 701M6540
• Device Lot Number: T09877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 03/24/2021; 03/24/2021; Not provided; Not provided
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 03/24/2021; 03/24/2021; 08/05/2025; 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2018
• 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: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White