MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. POLYAXIAL SCREW, DIA. 6.5MM X 40MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number	701M6540
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a vitality closure top migrated out of it's mating polyaxial screw post-operatively.The original construct was an l3/4 plif using a competitive cage.One month postoperatively, it was confirmed that the l3 left set screw was loosening, and three months after the surgery, it was confirmed that the set screw was completely popped off.A revision surgery was performed.This is report one of two for this event.
Additional Manufacturer Narrative
D4: the remainder of the udi number is unknown because the lot number is not available.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.
Additional Manufacturer Narrative
If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.Reference report 3012447612-2024-00369.
Event or Problem Description
It was reported that a vitality closure top migrated out of it's mating polyaxial screw post-operatively.The original construct was an l3/4 plif using a competitive cage.One month postoperatively, it was confirmed that the l3 left set screw was loosening, and three months after the surgery, it was confirmed that the set screw was completely popped off.A revision surgery was performed.This is report one of two 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: investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed no signs of damage.X-ray images were provided which show that a closure top has migrated out of its screw.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 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 vitality closure top migrated out of it's mating polyaxial screw post-operatively.The original construct was an l3/4 plif using a competitive cage.One month postoperatively, it was confirmed that the l3 left set screw was loosening, and three months after the surgery, it was confirmed that the set screw was completely popped off.A revision surgery was performed.This is report one of two for this event.

• Brand Name: POLYAXIAL SCREW, DIA. 6.5MM 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.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 20765982
• Report Number: 3012447612-2024-00368
• Device Sequence Number: 15778594
• Product Code: NKB
• UDI-Device Identifier: 00880304867505
• UDI-Public: (01)00880304867505(10)T11583
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2025

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: 701M6540
• Device Lot Number: T11583
• Was Device Available for Evaluation?: Yes
• 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; Not provided
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 01/29/2025; 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic