MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. POLYAXIAL OPEN ILIAC SCREW, DIA. 9.5MM X 100MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number	704M9500
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
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 one of four for this event.
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.
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 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 one of four for this event.
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 one 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.

• Brand Name: POLYAXIAL OPEN ILIAC SCREW, DIA. 9.5MM X 100MM
• 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: 19923533
• Report Number: 3012447612-2024-00193
• Device Sequence Number: 20861516
• Product Code: NKB
• UDI-Device Identifier: 00887868155598
• UDI-Public: (01)00887868155598
• 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: 704M9500
• 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