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

Model Number	233-150
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Event or Problem Description
The arm of the inserter is broken off.There was no report of patient involvement.
Additional Manufacturer Narrative
Corrected information: h3.Yes.H6.Investigation findings: 3251.Investigation conlusion: 22.H10.Visual inspection of the device confirmed the distal arm has sheared off.The distal arm did not return with the device.The arm of the inserter is a subcomponent which features an ipsilateral prong that attaches to the interbody spacer for insertion.This type of damage is consistent when force is applied during impaction/insertion of the interbody spacer causing the distal arm to detach from the shaft.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, pseudoarthrosis (i.E., non-union), fracture of the vertebra, neurological injury, and/or vascular or visceral injury." "possible adverse effects: possible adverse effects include: 1.Initial or delayed loosening, bending, dislocation, and/or breakage of device components.".

• 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 channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 18926888
• Report Number: 2027467-2024-00020
• Device Sequence Number: 17278223
• Product Code: OVD
• UDI-Device Identifier: 00190376382982
• UDI-Public: (01)00190376382982(10)EM46681
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K203742
• 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): 03/18/2024

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: 233-150
• Device Catalogue Number: 233-150
• Device Lot Number: EM46681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2022
• 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
• Patient Sex: Unknown