MAUDE Adverse Event Report: ALPHATEC SPINE, INC. CALIBRATE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	261-06185015
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implaint remains in situ.It is unknown whether the patient is experiencing any symptoms due to the event or is having revision surgery.The lot number was not provided; therefore, a review of device history records cannot be performed.A radiograph image confirmed the event.Based on the information provided, a root cause cannot be determined.If additional information and/or the implant is provided, a supplemental report will be filed accordingly.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.A calibrate ltx implant must not be re-expanded and reused if it has been filled with graft, as mechanical failure may occur.Possible adverse effects: initial or delayed loosening, bending, dislocation, and/or breakage of device components.Postoperative management: the surgeon should instruct the patient regarding the amount and time frame after surgery of any weight bearing activity.The increased risk of bending, dislocation, and/or breakage of the implanted devices, as well as an undesired surgical result are consequences of any type of early or excessive weight bearing, vibratory motion, falls, jolts or other movements preventing proper healing and/or fusion development.Implanted devices should be revised or removed if bent, dislocated, or broken.
Event or Problem Description
At the 6 months postoperative visit, radiograph images revealed a collapsed expandable cage.

• Brand Name: CALIBRATE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, 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: 19563767
• Report Number: 2027467-2024-00063
• Device Sequence Number: 12311410
• Product Code: MAX
• UDI-Device Identifier: 00190376522685
• UDI-Public: (01)00190376522685
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

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: 261-06185015
• Device Catalogue Number: 261-06185015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 06/18/2024
• 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: 63 YR
• Patient Sex: Female