MAUDE Adverse Event Report: ALPHATEC SPINE, INC. IDENTITI ALIF STANDALONE INTERBODY SYSTEM; 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 Type  malfunction  

Manufacturer Narrative

The graft bolt is a component of the alphatec identiti alif standalone interbody system, which is an integrated intervertebral body fusion device for use in anterior lumbar interbody fusion (alif) procedures used in patients for treatment, not diagnosis.Photographs/radiographs were not provided.The surgery date is unknown.The patient's bone quality and medical history are unknown.No additional information has been provided to alpahtec regarding this event.The distal portion of the graft bolt did not return to alphatec.The proximal portion of the broken graft bolt was returned to alphatec on 01/04/2023.Visual inspection of the graft bolt indicates thread damage to the medial portion of the bolt.This type of failure can occur during insertion if there is shallow or incorrect graft bolt trajectory which can cause it to impinge on the posterior end of the medial screw hole or posterior wall of the interbody spacer.This could lead to an increase in torque by the user resulting in the shear failure.A good faith effort is being made to obtain the applicable information relevant to the report.If additional information is obtained, 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.".

Event Description

Alphatec received information indicating a graft bolt broke during insertion.

• Brand Name: IDENTITI ALIF STANDALONE INTERBODY SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vide roble; carlsbad CA 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: 16301451
• MDR Text Key: 308871013
• Report Number: 2027467-2023-00003
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2023
• 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
• Device Lot Number: TO00835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2023
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2022
• 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