MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INSIGNIA; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number 336-0240;236-1-24018

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Post Operative Wound Infection (2446)

Event Date 05/21/2023

Event Type  Injury  

Manufacturer Narrative

No product returned for evaluation.Neither photographs nor radiographs images were provided.The identifying lot number was not provided; therefore, a review of the device history record could not be conducted.Based on the information provided, a root cause could not be determined.If additional information is provided, a supplemental report will be filed accordingly.

Event Description

On (b)(6) 2023, a patient underwent a 2-level anterior cervical discectomy and fusion at c5-c7.On (b)(6) 2023, due to an infection at the surgical site, the patient underwent an incision and drainage (i&d).During the i&d procedure, the surgeon found the left c7 screw backing out and the overlying portion of the blocker bent, but still covering the screw.The bent portion of the blocker was bumped during suction, causing it to break free from the plate/blocker assembly.The broken portion was removed from the patient.The remaining portion of the blocker, covering the right-side screw, along with the central attachment point of the blocker to the plate remained intact.The left c7 screw was removed, the wash out was completed, and the surgeon closed the wound.

• Brand Name: INSIGNIA
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 17159687
• MDR Text Key: 317534143
• Report Number: 2027467-2023-00038
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00190376329796
• UDI-Public: (01)00190376423517;(01)00190376329796
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 336-0240;236-1-24018
• Device Catalogue Number: 336-0240;236-1-24018
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other