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

Model Number 232-10-85-250

Device Problem Break (1069)

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

Event Date 11/20/2023

Event Type  malfunction  

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.".

Event Description

During an anterior lumbar interbody fusion procedure, the graft bolt broke in two when the surgeon was tightening.The head of the screw was recovered, but the shank remains in situ.There are no plans for revision surgery.Additional information was requested and is not available.

• Brand Name: IDENTITI
• 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 channel ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 18360621
• MDR Text Key: 331181478
• Report Number: 2027467-2023-00089
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 00190376369976
• UDI-Public: (01)00190376369976
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 232-10-85-250
• Device Catalogue Number: 232-10-85-250
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White