MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. POLYAXIAL SCREW, DIA. 7.5MM X 50MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number	701M7550
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: the remainder of the udi number is unknown because the lot number is not available.D10: vitality closure tops (07.02010.001) x13; screws (701m6545) x5; screws (701m6550) x2; screws (701m7545) x1; screws (701m7550) x5; and titanium rod (07.02013.003) x2.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 reports 3012447612-2024-00281 through 3012447612-2024-00292.
Event or Problem Description
It was reported that a revision surgery was performed to address six vitality closure tops that migrated out of their mating bone screws post-operatively.The patient had received a t10-s2 posterior lumbar fusion, and the closure tops popped off at l5 to s2.The patient claims they did not fall.The revision was performed to re-instrument using larger screws of a different product.This is report eight of twelve for this event.
Event or Problem Description
It was reported that a revision surgery was performed to address six vitality closure tops that migrated out of their mating bone screws post-operatively.The patient had received a t10-s2 posterior lumbar fusion, and the closure tops popped off at l5 to s2.The patient claims they did not fall.The revision was performed to re-instrument using larger screws of a different product.This is report eight of twelve for this event.
Additional Manufacturer Narrative
H6: additional method code: 4110.Additional information in h6: investigation type, findings, and conclusions.Device evaluation: the device was not returned; however, x-ray images were provided which show that several closure tops have migrated out of their screws.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to not fully seating the closure tops against the rods.Dhr review: the lot number was not reported and the device was not returned, therefore a dhr review is unable to be performed.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: POLYAXIAL SCREW, DIA. 7.5MM X 50MM
• 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.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 20472106
• Report Number: 3012447612-2024-00288
• Device Sequence Number: 7603266
• Product Code: NKB
• UDI-Device Identifier: 00880304867949
• UDI-Public: (01)00880304867949
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: Lay User/Patient
• Device Catalogue Number: 701M7550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic