MAUDE Adverse Event Report: ALPHATEC SPINE, INC. IDENTITI; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	134-3-35-16
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implant is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Event or Problem Description
It was reported that the screw broke during insertion, leaving about two-thirds of the screw shank inside the spacer and the patient.The remaining part of the screw was successfully removed.
Additional Manufacturer Narrative
Corrected information: h3.Yes h6.Investigation findings: 3252 investigation conclusions: 18, 61 device evaluation: visual inspection confirms the head of the screw is sheared at the second to last thread.It was reported that the screw was inserted at a shallow angle.If the screw trajectory is inserted shallow, there becomes a point where the screw is being driven into the interbody spacer itself rather than into a position to seat within the screw pocket of the interbody spacer.This will lead to an increase in torque required to advance the screw as the titanium screw is interfacing with the titanium interbody spacer.When the user continues to apply increased torque to try to advance the screw while it is in the wrong trajectory and contacting the metal in the spacer, the screw will fill and shear at its weakest point; at the minor diameter of the screwhead.This shear at the second to last thread is consistent with this failure mode as that is the weakest point.Review of device history records showed no manufacturing or processing related irregularities.Labeling review: warnings/cautions: potential risks identified with the use of these fusion devices, which may require additional surgery, include device component failure, loss of fixation, pseudarthrosis (i.E., non-union), fracture of the vertebra, neurological injury, and/or vascular or visceral injury.Attempting to rotate the locking mechanism over screws that are not fully seated within the interbody implant may result in damage to the locking mechanism.Possible adverse effects: initial or delayed loosening, bending, dislocation and/or breakage of device components.

• Brand Name: IDENTITI
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer (Section G): 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: 20538595
• Report Number: 2027467-2024-00146
• Device Sequence Number: 6697319
• Product Code: OVE
• UDI-Device Identifier: 00190376285344
• UDI-Public: (01)00190376285344(10)RE00174
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K202812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 10/25/2024

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: 134-3-35-16
• Device Catalogue Number: 134-3-35-16
• Device Lot Number: RE00174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2023
• 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: Male