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

Model Number 232-10-85-300

Device Problem Break (1069)

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

Event Date 08/15/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, a patient underwent an anterior lumbar interbody fusion procedure.After inserting the spacer, pilot hole prep was performed for the graft bolt using the trephine punch.The trephine was properly seated in the center hole and deployed.It was reported half-way during insertion the graft bolt snapped.The top portion was removed leaving the threaded end within in the spacer implanted in the patient.Lastly, the surgeon implanted posterior percutaneous pedicle screws.At the end of the procedure, it was reported the spacer was well placed.There were no patient symptoms or complications as a result of this event.

Manufacturer Narrative

The top portion of the graft bolt has not returned for evaluation.The identifying lot number was not provided.The root cause could not be determined.If additional information is provided, a supplemental report will be submitted.Labeling review: "warnings/cautions/precautions: care should be taken in performing screw hole preparation to facilitate a proper graft bolt insertion trajectory and implantation.Confirm under fluoroscopy that the graft bolt insertion angle is as close as possible to a 40° trajectory.A shallow or incorrect graft bolt trajectory may result in encroachment of the spacer and lead to graft bolt breakage.".

• Brand Name: IDENTITI ALIF
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• 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: 17748399
• MDR Text Key: 323493088
• Report Number: 2027467-2023-00058
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 00190376369990
• UDI-Public: (01)00190376369990
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K203742
• 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: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 232-10-85-300
• Device Catalogue Number: 232-10-85-300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1