MAUDE Adverse Event Report: ALPHATEC SPINE, INC INVICTUS¿ SPINAL FIXATION SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	17125
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During surgery, the rod would not properly lock to the mis rod inserter.There appeared to be lack of necessary rigid interface between the rod and inserter, which made it difficult to pass and seat the rod.This caused a delay in surgery.No patient injury reported.
Additional Manufacturer Narrative
Review of device history records was performed.No irregularities were identified during manufacturing or inspection.The instrument returned to atec on 10/22/2021.There were no signs of visible damage.The threaded piston functioned properly with full stroke lock to unlock.The t25 threading feels smooth and proper.No sign of damage or wear to the t25 hexalobe.Instrument lock pins are intact.The instrument was tested and verified for intended use and functionality.No defects found.It is fully operational.The root cause is likely use error.

• Brand Name: INVICTUS¿ SPINAL FIXATION SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): 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: 12833094
• Report Number: 2027467-2021-00071
• Device Sequence Number: 4638670
• Product Code: LXH
• UDI-Device Identifier: 00190376269573
• UDI-Public: 00190376269573
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K203056
• 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): 10/18/2021

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?: Yes
• Device Model Number: 17125
• Device Catalogue Number: 17125
• Device Lot Number: CT36570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2020
• 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: Hospitalization
• Patient Sex: Unknown