MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. CANNULATED POLYAXIAL SCREW 7.5MM X 35MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	824M7535
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
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 a vital mis screw head broke off during implant removal surgery.Implant removal was performed because the closure top had come off and fusion was completed.There was no patient harm or procedural delay.This is report one of two for this event.
Event or Problem Description
It was reported that a vital mis screw head broke off during implant removal surgery.Implant removal was performed because the closure top had come off and fusion was completed.There was no patient harm or procedural delay.This is report one of two for this event.
Additional Manufacturer Narrative
Additional information in h6: investigation type, findings, and conclusions.A lot number was not provided, so a dhr review could not be performed.The device was not returned, so an evaluation could not be performed.The complaint is unrefuted for one vital mis tl cann poly lt 7.5x35mm for the failure of fracture during removal and loosening of closure top.The failure is believed to be attributed to hard patient bone leading to excessive forces being applied to the screw or other unknown patient or surgical factors.The failure of post-op loosening of closure top is believed to be attributed to inadequate final tightening during the initial surgery, or other unknown patient or surgical factors.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.Reference report 3012447612-2025-00326.

• Brand Name: CANNULATED POLYAXIAL SCREW 7.5MM X 35MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 23304811
• Report Number: 3012447612-2025-00325
• Device Sequence Number: 13268940
• Product Code: NKB
• UDI-Device Identifier: 00887868514234
• UDI-Public: (01)00887868514234
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203507
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 03/22/2026

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: 824M7535
• 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
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic