MAUDE Adverse Event Report: NEXT ORTHOSURGICAL NEX-D2 POSTERIOR FIXATION SYSTEM; BONE TAP, MIS, 4.5MM

Model Number	CBZB005-45
Medical Device Problem Codes	Material Fragmentation (1261); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
N/a.
Event or Problem Description
During fixation of l4 and l5 vertabrea the tip of the bone tap 4.5mm pn cbzb005-45 ln 0001217c1 broke while tapping l5.A snapping sound was heard and fragments of the tip of the bone tap became lodged inside the bone and could not be removed.L5 was skipped and instead s1 was used in its place.

• Brand Name: NEX-D2 POSTERIOR FIXATION SYSTEM
• Common Device Name: BONE TAP, MIS, 4.5MM
• Manufacturer (Section D): NEXT ORTHOSURGICAL; 3270 corporate view suite a; vista CA 92081
• Manufacturer (Section G): NEXT ORTHOSURGICAL; 3270 corporate view, suite a; vista CA 92081
• Manufacturer Contact: alicia hernandez ; 3270 corporate view, suite a; vista, CA 92081 ; 7602953600
• MDR Report Key: 22997742
• Report Number: 3010020754-2025-00003
• Device Sequence Number: 12963399
• Product Code: LXH
• UDI-Device Identifier: 00840314121103
• UDI-Public: 00840314121103
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/29/2025

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?: No
• Device Model Number: CBZB005-45
• Device Catalogue Number: CBZB005-45
• Device Lot Number: 0001217C1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian