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

Model Number	15905-065-050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Around one year postoperatively, a patient underwent revision surgery to remove a broken osseoscrew.
Additional Manufacturer Narrative
The implant has not returned.The identifying lot number was not provided; therefore, a review of the device history records could not be performed.The root cause could not be determined at this time.If additional information is received, a supplemental report will be submitted.

• 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: 14190532
• Report Number: 2027467-2022-00021
• Device Sequence Number: 19945187
• Product Code: NKB
• UDI-Device Identifier: 00190376243832
• UDI-Public: 00190376243832
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K202327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 03/24/2022

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
• Device Catalogue Number: 15905-065-050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown