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

Model Number	134-07181607-S
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implant did not return for evaluation.Photographs were provided which confirm the event.The locking mechanism has broken off from the rest of the implant.Radiograph images revealed the superior screw of the spacer had begun backing out.Engineering reviewed the photographs provided and concluded that the screw was likely backing out due to the locking mechanism breaking off.Review of the device history records showed no manufacturing or processing related irregularities.Alphatec spine is submitting this report to comply with the fda regulations 21 cfr 803.Alphatec spine has made reasonable efforts to provide as much relevant information as available.Any field that is left blank was not known at the time of this submission.If additional information is provided, a supplemental report will be submitted.Labeling review: warnings/cautions/precautions: risk factors that may affect successful surgical outcomes include alcohol abuse, obesity, patients with poor bone, muscle and/or nerve quality.Patients who use tobacco or nicotine products should be advised of the consequences that an increased incidence of non-union has been reported with patients who use tobacco or nicotine products.Attempting to rotate the locking mechanism over screws that are not fully seated within the interbody implant may result in damage to the locking mechanism.Possible adverse effects: initial or delayed loosening, bending, dislocation and/or breakage of device components.Postoperative management: immobilization should be considered in order to prevent bending, dislocation, or breakage of the implanted device in case of delayed, malunion, or nonunion of bone.Immobilization should continue until a complete bone fusion mass has developed and been confirmed.
Event or Problem Description
It was reported a radiograph image revealed the superior angled screw had begun to back out of the spacer.During revision surgery, a small fragment of the locking mechanism was found detached and anterior to the spacer.Both screws and the spacer were removed from the spacer.A new spacer was implanted.
Additional Manufacturer Narrative
B1.Adverse event.H1.Serious injury.

• Brand Name: IDENTITI CERVICAL STANDALONE INTERBODY SYSTEM
• 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: 21172804
• Report Number: 2027467-2024-00179
• Device Sequence Number: 19901886
• Product Code: OVE
• UDI-Device Identifier: 00190376286181
• UDI-Public: (01)00190376286181(10)10100804
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K202812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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: 134-07181607-S
• Device Catalogue Number: 134-07181607-S
• Device Lot Number: 10100804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2024
• 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
• Patient Age: 49 YR
• Patient Sex: Male