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

Model Number	232-10-85-250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2027467-2023-00089
• Device Sequence Number: 7731148
• Product Code: OVD
• UDI-Device Identifier: 00190376369976
• UDI-Public: (01)00190376369976
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K203742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2023

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: 232-10-85-250
• Device Catalogue Number: 232-10-85-250
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 42 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White