MAUDE Adverse Event Report: ALPHATEC SPINE, INC. ALPHATEC NAVIGATION INSTRUMENTS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	17950-N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned device revealed the distal hexalope tip is sheared off.The most likely root cause is torsional loading consistent with the intended use of the device; however, excessive torque applied during final tightening likely exceeded the design strength of the tip.Review of the device history record confirmed that the instrument met all dimensional specifications at the time of manufacture and successfully passed all required inspections, with no nonconformities identified.There was no manufacturing issues identified that would have contributed to this event.
Event or Problem Description
The tip of the screwdriver broke off.

• Brand Name: ALPHATEC NAVIGATION INSTRUMENTS
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer (Section G): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: michael hendrickson ; 1950 camino vida roble; carlsbad, CA 92008 ; 7603566777
• MDR Report Key: 25028608
• Report Number: 2027467-2026-00073
• Device Sequence Number: 13295306
• Product Code: OLO
• UDI-Device Identifier: 00190376475202
• UDI-Public: (01)00190376475202(10)EM50862
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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 Model Number: 17950-N
• Device Catalogue Number: 17950-N
• Device Lot Number: EM50862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown