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

Model Number	336-0240;236-1-24018
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	05/21/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2027467-2023-00038
• Device Sequence Number: 5744676
• Product Code: KWQ
• UDI-Device Identifier: 00190376329796
• UDI-Public: (01)00190376423517;(01)00190376329796
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K213443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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): 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 336-0240;236-1-24018
• Device Catalogue Number: 336-0240;236-1-24018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2023
• Initial Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown