MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. POLYAXIAL SCREW (DIA. 5.5 MM X 30 MM L); APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	07.01708.020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
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 3012447612-2025-00074.
Event or Problem Description
It was reported that a revision surgery was performed to address a patient¿s construct that broke down at t2 and c4 (the rod was not secured on the screw shanks).During the surgery, the surgeon noticed that the tulip heads of two virage screws popped off.This is report two of two for this event.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.Corrections in h3 and h6: component code.Additional information in h6: investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the lower housing on the tulip has fractured, resulting in the screw disassembling.Root cause: a scar was opened for further investigation.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 medical¿s control.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.
Event or Problem Description
It was reported that a revision surgery was performed to address a patient¿s construct that broke down at t2 and c4 (the rod was not secured on the screw shanks).During the surgery, the surgeon noticed that the tulip heads of two virage screws popped off.This is report two of two for this event.

• Brand Name: POLYAXIAL SCREW (DIA. 5.5 MM X 30 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: 21551863
• Report Number: 3012447612-2025-00075
• Device Sequence Number: 14557920
• Product Code: KWP
• UDI-Device Identifier: 00889024328372
• UDI-Public: (01)00889024328372(10)AAG
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K133556
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/24/2025

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: Lay User/Patient
• Device Catalogue Number: 07.01708.020
• Device Lot Number: AAG
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VIRAGE ROD, UNKNOWN SIZE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic