MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. POLYAXIAL OPEN ILIAC SCREW, DIA. 8.5MM X 90MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number	704M8590
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
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 reports 3012447612-2024-00193 through 3012447612-2024-00196.
Event or Problem Description
It was reported that post-op x-rays revealed that two vital set screws migrated out of both open iliac screws implanted at s2a1.The patient impact is currently unknown and it is unclear whether a revision will be scheduled at this time.This is report two of four for this event.
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.
Event or Problem Description
It was reported that post-op x-rays revealed that two vital set screws migrated out of both open iliac screws implanted at s2a1.The patient impact is currently unknown and it is unclear whether a revision will be scheduled at this time.This is report two of four for this event.
Additional Manufacturer Narrative
D4: the remainder of the udi number is unknown because the lot number is not available.H6: additional method code: 4109 additional information in d4: udi number and h6: component, investigation type, findings, and conclusions.Device evaluation: the device was not returned, however an x-ray image was provided which shows that the closure tops have migrated out of the two iliac 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.
Event or Problem Description
It was reported that post-op x-rays revealed that two vital set screws migrated out of both open iliac screws implanted at s2a1.The patient impact is currently unknown and it is unclear whether a revision will be scheduled at this time.This is report two of four for this event.

• Brand Name: POLYAXIAL OPEN ILIAC SCREW, DIA. 8.5MM X 90MM
• 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: 19923403
• Report Number: 3012447612-2024-00194
• Device Sequence Number: 12846195
• Product Code: NKB
• UDI-Device Identifier: 00887868155154
• UDI-Public: (01)00887868155154
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K183550
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 704M8590
• Was Device Available for Evaluation?: No
• 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; Not provided
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/17/2024; 12/30/2024
• 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
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic