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

Model Number 17125

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2021

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 280928070
• Report Number: 2027467-2021-00071
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00190376269573
• UDI-Public: 00190376269573
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• 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
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization