MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. POLYAXIAL SCREW (DIA. 5.0 MM X 25 MM L); APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	07.01708.011
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: the remainder of the udi number is unknown because the lot number is not available.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.
Event or Problem Description
It was reported that the tulip head of a virage polyaxial screw completely fractured from the shank of the screw intra-operatively.The screw shaft was not able to be retrieved from the patient so it was left; there was a delay of 10-15 minutes while trying to retrieve the broken part of the screw.
Additional Manufacturer Narrative
Corrections in d4: lot & udi numbers, d9, and h3.Additional information in h4.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 the tulip head of a virage polyaxial screw completely fractured from the shank of the screw intra-operatively.The screw shaft was not able to be retrieved from the patient so it was left; there was a delay of 10-15 minutes while trying to retrieve the broken part of the screw.
Additional Manufacturer Narrative
Corrections in h3.Additional information in h6: methods, results, and conclusions.H3: "device evaluation anticipated, but not yet begun (02)" no longer applies but cannot be removed.Inspection the returned device matches the information in the complaint file and was examined.Visual inspection revealed the screw shank fractured.Dhr review the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge¿s control.Potential root cause a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to excessive torque applied to the screw during insertion, possibly due to improper or insufficient bone prep.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 the tulip head of a virage polyaxial screw completely fractured from the shank of the screw intra-operatively.The screw shaft was not able to be retrieved from the patient so it was left; there was a delay of 10-15 minutes while trying to retrieve the broken part of the screw.

• Brand Name: POLYAXIAL SCREW (DIA. 5.0 MM X 25 MM L)
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 22535015
• Report Number: 3012447612-2025-00272
• Device Sequence Number: 7425393
• Product Code: KWP
• UDI-Device Identifier: 00889024328280
• UDI-Public: (01)00889024328280(10)AAO
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133556
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 12/11/2025

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: 07.01708.011
• Device Lot Number: AAO
• Was Device Available for Evaluation?: Yes
• 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: 07/17/2025
• Supplement Report FDA Received Date: 08/20/2025; 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2020
• 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: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic