MAUDE Adverse Event Report: ALPHATEC SPINE, INC INVICTUS OCT SPINAL FIXATION SYSTEM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	19000-55-30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device is currently under investigation.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
On (b)(6) 2023, a patient underwent a posterior cervical fusion procedure.During screw insertion, the ratcheting handles were torquing out and would not fully drive the screw in.The polyaxial screw broke just below the tulip.All the pieces were retrieved, and a new screw was inserted.No additional information was provided.
Additional Manufacturer Narrative
B2.80, (b)(6) 1942.B3.Male.H6.Investigation findings: 3243.Investigation conclusion: 61.H10: device evaluation: a review of the dhr indicated no remarkable manufacturing or quality items that would have impacted performance relative to the complaint beyond the intended design.There are no clear indications that the design, manufacturing, or initial quality of the implant contributed to the complaint.Qty (b)(4) of pn 19000-55-30 ln to00550 were manufactured to drawing rev b and released into inventory on 01/18/2022.The invictus oct polyaxial screw pn 19000-55-30 was visually and physically examined upon receipt and showed no apparent signs of manufacturing defect.The screw was received not intact and returned with a shank facture at the neck of the screw.Additional damage and markings to the screw were observed and are attributed to the removal and retrieval of the implant during the surgery.The returned implant shank clearly indicates a fracture at the neck most likely due to excess torsional load.The following testing and characterization data for this design is summarized below for an evaluated 4.5mm screw in comparison to the returned 5.5mm screw which share the same neck diameter of.109" (2.77mm).4.5mm screws were torqued to failure in a vise as well as inserted into 40 and 50 pcf bone foam in order to compare to the complaint failures.Results and images are captured in the tables below.The 19000-45-40 failures exhibited similar witness marks as those seen in the investigation implant for both strict torsional failures & lateral bending failures.The root cause is due to the torsional load experienced exceeded the design limitations for the shank and design tested and approved.

• Brand Name: INVICTUS OCT SPINAL FIXATION SYSTEM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vide roble; carlsbad AR 92008
• Manufacturer (Section G): ALPHATEC SPINE, INC.; 1950 camino vide roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vide roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 16402168
• Report Number: 2027467-2023-00007
• Device Sequence Number: 12107202
• Product Code: NKG
• UDI-Device Identifier: 00190376303697
• UDI-Public: (01)00190376303697(10)TO00550
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K203125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2023

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: 19000-55-30
• Device Catalogue Number: 19000-55-30
• Device Lot Number: TO00550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2022
• 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
• Patient Sex: Unknown