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

Model Number	17139-055-N
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection of the returned device revealed the cannulated threaded tip had fractured and separated at the 50mm depth grove indicator.Inspection under magnification revealed circular fracture lines indicative of a torsional overload.Possible adverse effects: the following complications and adverse reactions have been shown to occur with the use of similar spinal instrumentation.These effects and any other known by the surgeon must be discussed with the patient preoperatively.1.Initial or delayed loosening, disassembly, bending, dislocation, and/or breakage of device components.
Event or Problem Description
It was reported the tip of a tap broke off inside the pedicle during a spinal procedure.The surgeon was able to retrieve the tip from the bone.There were no patient symptoms or complications reported as result of this event.

• 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: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 18489736
• Report Number: 2027467-2023-00096
• Device Sequence Number: 14375348
• Product Code: OLO
• UDI-Device Identifier: 00190376319223
• UDI-Public: (01)00190376319223(10)8698308R
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/10/2024

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: 17139-055-N
• Device Catalogue Number: 17139-055-N
• Device Lot Number: 8698308R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2021
• 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: Male