MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. POLYAXIAL SCREW (DIA. 3.5 MM X 22 MM L); APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	07.01702.015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: additional method code: 4110.Device evaluation: the device was not returned, but x-rays provided revealed the weld on the lower housing has fractured.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown patient or surgical factors.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 during a 4-month post-operation check-up, a virage screw with a fractured tulip head at the welds was found via x-ray.The patient is currently experiencing no symptoms and a revision surgery is not planned.

• Brand Name: POLYAXIAL SCREW (DIA. 3.5 MM X 22 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: 21638844
• Report Number: 3012447612-2025-00114
• Device Sequence Number: 8510452
• Product Code: KWP
• UDI-Device Identifier: 00889024327085
• UDI-Public: (01)00889024327085(10)AAR
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133556
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2025

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: Lay User/Patient
• Device Catalogue Number: 07.01702.015
• Device Lot Number: AAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2021
• 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
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic