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

Model Number	134-07161407-S
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Failure of Implant (1924)
Date of Event	09/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Around three months after surgery, the patient reported experiencing pain while swallowing.A radiograph was performed, which showed that the blocker on the spacer had become unlocked and was backing out.Revision surgery was performed.
Additional Manufacturer Narrative
The implant is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Additional Manufacturer Narrative
Correction: d1: identiti cervical standalone interbody system.H3: yes.H6: investigation findings: 3251.Investigation conclusions: 4315.Device evaluation: visual inspection of the spacer found the blocker no longer attached and missing.Tissue is present within the cannula where the blocker typically sits, but remnants of the blocker remain beneath it, indicating it sheared at the interface with the cross pin.There is cosmetic damage to the faceplate which likely occurred during the removal process.The shear pattern observed near the cross pin indicates that the blocker may have been structurally comprised under in-situ dynamic loading.However, without the blocker available for evaluation, a definitive root cause cannot be determined.

• 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: 20475615
• Report Number: 2027467-2024-00125
• Device Sequence Number: 15356558
• Product Code: OVE
• UDI-Device Identifier: 00190376286129
• UDI-Public: (01)00190376286129(10)10080909
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K202812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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): 10/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 134-07161407-S
• Device Catalogue Number: 134-07161407-S
• Device Lot Number: 10080909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male