MAUDE Adverse Event Report: ALPHATEC SPINE, INC. IDENTITI ALIF INTERBODY SYSTEMS; ELEVATOR

Model Number	168-30
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a distractor broke during a case.A spring from the distractor was left in the patient.
Additional Manufacturer Narrative
The device is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Additional Manufacturer Narrative
Correction: h3.Yes h6.Investigation findings: 3252 investigation conclusions: 61 device evaluation: visual inspection confirms the complaint.The paddle has sheared from one of the distractor arms.The paddle was returned, but the spring for the button was not.The root cause is likely that the instrument was twisted while attempting to distract the disc space causing excess load from this torsion and bending.Review of device history records showed no manufacturing irregularities.Labeling review: warnings/cautions/precautions: potential risks identified with the use of these fusion devices, which may require additional surgery, include device component failure, loss of fixation, pseudarthrosis (i.E., non-union), fracture of the vertebra, neurological injury, and/or vascular or visceral injury.Possible adverse effects: initial or delayed loosening, bending, dislocation, and/or breakage of device components.Physiological reaction to implant devices due to foreign body intolerance including inflammation, local tissue reaction, seroma, and possible tumor formation.

• Brand Name: IDENTITI ALIF INTERBODY SYSTEMS
• Common Device Name: ELEVATOR
• 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: michael hendrickson ; 1950 camino vida roble; carlsbad, CA 92008 ; 7603566777
• MDR Report Key: 21934953
• Report Number: 2027467-2025-00077
• Device Sequence Number: 18113911
• Product Code: HTE
• UDI-Device Identifier: 00190376243658
• UDI-Public: (01)00190376243658(10)FD9618711
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/30/2025

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: 168-30
• Device Catalogue Number: 168-30
• Device Lot Number: FD9618711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown