MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. CLOSURE TOP; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	3301-1
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that three sequoia closure tops were stripped during surgery.A fourth closure top was used to complete the surgery.There was no patient impact; however, there was a 30 minute delay.This is report two of three for this event.
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.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.Reference reports 3012447612-2025-00207 through 3012447612-2025-00209.
Event or Problem Description
It was reported that three sequoia closure tops were stripped during surgery.A fourth closure top was used to complete the surgery.There was no patient impact; however, there was a 30 minute delay.This is report two of three for this event.
Additional Manufacturer Narrative
Corrections in d9 and h3.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 drive mechanism has deformation damage.Root cause: this event could possibly be attributed to off-axis forces applied during use or not fully seating the driver in the driver pocket.Dhr review: there was one non-conformance associated with this lot related to cut samples not received by the supplier at inspection.There were 3278 non-conforming pieces in the lot.Per the disposition of ncr 5895, nine pieces were sent back to the vendor.The remaining 3269 were dispositioned as standard rework prior to the lot leaving highridge medical control.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.

• Brand Name: CLOSURE TOP
• 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: 22020370
• Report Number: 3012447612-2025-00208
• Device Sequence Number: 9412437
• Product Code: NKB
• UDI-Device Identifier: 00889024334861
• UDI-Public: (01)00889024334861(10)ABL
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K131980
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

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: Health Professional
• Device Catalogue Number: 3301-1
• Device Lot Number: ABL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/14/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2023
• 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: Unknown
• Patient Ethnicity: Non Hispanic