MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. POLYAXIAL SCREW (DIA. 6.5MM X 45 MM L); VITALITY SPINAL FIXATION SYSTEM

Catalog Number	824M6545
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a closure top was found to have backed out of its mating pedicle screw on x-rays taken during a post-op follow-up visit.A small of amount of kyphosis developed around the screw but did not cause any pain for the patient.A revision surgery was subsequently performed to remove the construct because it was no longer needed.This is report two of two for this event.
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.Reference report: 3012447612-2023-00023.
Additional Manufacturer Narrative
Device evaluation the returned devices were examined.For the screw: 2 screws were returned with the same lot number, so the identity of the device with reported malfunction cannot be confirmed.Visual inspection revealed that one of the screws had clear damage to the threading of the tulip head, and the other did not.For the closure top: 3 closure tops were returned with the same lot number, so the identity of the device with reported malfunction cannot be confirmed.Visual inspection revealed no clear damage to the threading or drive features of any of the devices.The wear pattern on the bottom of the devices suggest that one of them may not have been fully seated against the rods.The associated rods were also inspected and showed wear patterns of use with the closure tops.Dhr review per dhr review, the part was likely conforming when it left zimvie control.Potential cause root cause was unable to be determined.This event could possibly be attributed to unknown trauma or patient factors.Device usage this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
Event or Problem Description
It was reported that a closure top was found to have backed out of its mating pedicle screw on x-rays taken during a post-op follow-up visit.A small of amount of kyphosis developed around the screw but did not cause any pain for the patient.A revision surgery was subsequently performed to remove the construct because it was no longer needed.This is report two of two for this event.

• Brand Name: POLYAXIAL SCREW (DIA. 6.5MM X 45 MM L)
• 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: sabrina abla ; 10225 westmoor dr.; na; westminster, CO 80021 ; 7206965158
• MDR Report Key: 16362257
• Report Number: 3012447612-2023-00024
• Device Sequence Number: 7544361
• Product Code: NKB
• UDI-Device Identifier: 00887868513831
• UDI-Public: (01)00887868513831(10)SBM135481
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K203507
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2024

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: Other
• Device Catalogue Number: 824M6545
• Device Lot Number: SBM135481
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/01/2023
• 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: 01/17/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 18 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic