MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. TOP LOADING POLY SCREW ASSEMBLIES 7.5X40MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number	07.02000.116
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	05/18/2022
Type of Reportable Event	Serious Injury
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 report 3012447612-2022-00161.
Event or Problem Description
It was reported that a revision surgery was performed to remove and replace two 6.5x50mm vitality screws that broke post-operatively on both sides of s1.An additional level was also instrumented.This is report two of two for this event.
Additional Manufacturer Narrative
Corrections in d1 and d4: catalog number and lot number.Without a product return, no product evaluation is able to be conducted.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.
Event or Problem Description
It was reported that a revision surgery was performed to remove and replace two 6.5x50mm vitality screws that broke post-operatively on both sides of s1.An additional level was also instrumented.This is report two of two for this event.
Additional Manufacturer Narrative
Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: the returned products were visually inspected.Both pedicle screws were confirmed to have broken at the top of the neck on the threaded shaft.There is damage to the threads that is consistent with grabbing the top of the threaded shafts with another instrument to remove them.Potential root cause a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to off-axis forces applied during implantation or post-operatively.Additionally, the failure could be related to excess torque applied during implantation.Dhr review the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the devices were likely conforming when they left zimvie¿s control.Device usage: this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
Event or Problem Description
It was reported that a revision surgery was performed to remove and replace two 6.5x50mm vitality screws that broke post-operatively on both sides of s1.An additional level was also instrumented.This is report two of two for this event.

• Brand Name: TOP LOADING POLY SCREW ASSEMBLIES 7.5X40MM
• 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.; na; westminster CO 80021
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 14804777
• Report Number: 3012447612-2022-00162
• Device Sequence Number: 4844431
• Product Code: NKB
• UDI-Device Identifier: 00889024002135
• UDI-Public: (01)00889024002135(10)W572821(11)180504
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K150896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2022

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: Health Professional
• Device Catalogue Number: 07.02000.116
• Device Lot Number: W572821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 07/22/2022; 09/01/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 08/12/2022; 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2018
• 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: Hospitalization; Required Intervention
• Patient Sex: Female