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	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, during a surgical operation procedure involving spinal fixation of the vertebra t8 and t9, complications arose with the instrumentation.While tapping the vertebrae, the tip of the initial 4.5mm bone tap fractured and became lodged within the t8 vertebral body.Subsequently, a second 4.5mm bone tap was used for t9, the tip of this bone tap also became lodged.Resulting in two sperate bone tap fragments retained within the respective vertebrae (t8 and t9).
Additional Manufacturer Narrative
Bone taps requested but will not be returned.

• 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: 22766514
• Report Number: 3010020754-2025-00002
• Device Sequence Number: 15849369
• 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: 2025
• 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): 07/16/2025

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
• Operator of Device: Health Professional
• Device Model Number: CBZB005-45
• Device Catalogue Number: CBZB005-45
• Device Lot Number: 002156D13 & 003288F02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 08/09/2025
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian