MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. CANNULATED POLYAXIAL SCREW 4.5X45MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number	801M4545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 2 cut rods (07.02022.002 & unknown), 7 closure tops (07.02010.001), 2 additional screws (801m4545).Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference reports 3012447612-2024-00197 through 3012447612-2024-00202.
Event or Problem Description
It was reported that a t10-pelvis revision surgery was conducted to correct six vitality screws that were found to have fractured or bent post-operatively.No further information regarding patient impact or revision type is available at this time.This is report three of six for this event.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.H6: additional method code: 4110.Corrections in h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the screw shank has fractured.Additionally x-ray images were provided which show the screw has fractured.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 a t10-pelvis revision surgery was conducted to correct six vitality screws that were found to have fractured or bent post-operatively.No further information regarding patient impact or revision type is available at this time.This is report three of six for this event.

• Brand Name: CANNULATED POLYAXIAL SCREW 4.5X45MM
• 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.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 19933876
• Report Number: 3012447612-2024-00199
• Device Sequence Number: 2760280
• Product Code: NKB
• UDI-Device Identifier: 00887868254611
• UDI-Public: (01)00887868254611(10)T11013
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K183550
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/29/2024

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: Lay User/Patient
• Device Catalogue Number: 801M4545
• Device Lot Number: T11013
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2020
• 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: Female
• Patient Ethnicity: Non Hispanic