MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. BOTTOM LOADING POLY OPEN ILIAC SCREW ASSEMBLIES 8.5X80; VITALITY SPINAL FIXATION SYSTEM

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the iliac tulip disengaged with the screw shank with little to no pressure.The surgeon was using the screw head turner and the tulip popped off.The screw was removed and replaced with a different iliac screw.There was no reported impact on the patient.
Additional Manufacturer Narrative
Corrected information in h3.Additional information in h6: component codes, type of investigations, findings, conclusions.This follow-up report is being submitted to relay additional information.Device evaluation: visual inspection revealed the tulip head has disassociated with from the screw shank.Potential cause the cause of the damage cannot be determined at this time since there is no information available regarding how the screw was being used or handled at the time of the damage.Dhr review per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.Device use this device is used for treatment.If additional information is received that changes the information in this report, a follow-up report will be submitted.
Event or Problem Description
It was reported that the iliac tulip disengaged with the screw shank with little to no pressure.The surgeon was using the screw head turner and the tulip popped off.The screw was removed and replaced with a different iliac screw.There was no reported impact on the patient.

• Brand Name: BOTTOM LOADING POLY OPEN ILIAC SCREW ASSEMBLIES 8.5X80
• Common Device Name: VITALITY SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 11869850
• Report Number: 3012447612-2021-00185
• Device Sequence Number: 19627924
• Product Code: NKB
• UDI-Device Identifier: 00889024009592
• UDI-Public: (01)00889024009592(10)416982
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2021

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 07.02050.166
• Device Lot Number: 416982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1