MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS¿ OSSEOSCREW® SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	15905-065-050; 17814-050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The expansion shaft has not returned for evaluation.The reduction screw remains in-situ.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
A 6.5 x 50mm reduction screw was loaded on the screwdriver and a 50mm expansion shaft was inserted into the screw.The screw was implanted under fluoroscopy and the expansion shaft was visible.There was no expansion.The surgeon released the tension and tried to remove the expansion shaft.The tip of the shaft broke off into the screw and could not be removed.No patient injury reported.

• Brand Name: INVICTUS¿ OSSEOSCREW® SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 12833097
• Report Number: 2027467-2021-00073
• Device Sequence Number: 4638671
• Product Code: NKB
• UDI-Device Identifier: 00190376243832
• UDI-Public: 00190376243832
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K202327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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: 15905-065-050; 17814-050
• Device Catalogue Number: 15905-065-050; 17814-050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Female