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

Model Number	325-07103015
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implant remains in-situ.Radiograph images were provided which confirm the event.The lot number was not provided; therefore, a review of device history records cannot be performed.Based on the information provided, the 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: these implants are used only to provide internal fixation, in conjunction with graft and supplemental fixation, during the bone fusion process.A successful result may not be achieved in every instance.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.A calibrate ccx 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 movement preventing proper healing and/or fusion development.Implanted devices should be revised or removed if bent, dislocated, or broken.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
At the 8 weeks postoperative visit, radiograph images revealed a collapsed expandable cage.The patient is asymptomatic.No plans for revision surgery.The surgeon will continue to monitor the patient.

• 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: 19921264
• Report Number: 2027467-2024-00099
• Device Sequence Number: 7218755
• Product Code: MAX
• UDI-Device Identifier: 00190376533018
• UDI-Public: (01)00190376533018
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K232504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 08/06/2024

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: 325-07103015
• Device Catalogue Number: 325-07103015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 08/06/2024
• 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 Sex: Unknown