MAUDE Adverse Event Report: NUVASIVE INC. ARCHON ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	8787474
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Even though no product has been returned for evaluation alleged event was confirmed by a lateral radiograph provided.During further investigation it was identified due to patients bone quality surgeon decided to utilize rescue screws in conjunction with the self-centering awl not utilizing a guide, incidentally some of the screw heads were left proud which interfered with the lock rotation and lock fracture.Devices were replaced with another manufacturer product no patient injury has been reported.Labeling review: 'do not use self-centering awls without a drill guide.For freehand screw insertion where an awl is desired, use of the self-centering awl is required at all times to avoid incomplete or improper locking"."care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient"."only patients that meet the criteria described in the indications should be selected.Patient condition and/or predispositions such as those addressed in the aforementioned contraindications should be avoided".''potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)"."all implants should be used only with the appropriately designated instrument"."contraindications any conditions that preclude the possibility of fusion are relative contraindications.These include but are not limited to: cancer, fever, mental illness, alcoholism or drug abuse, osteoporosis or osteopenia''.
Event or Problem Description
On (b)(6) 2019 a patient underwent an anterior cervical discectomy fusion procedure at levels c3-7.As per reporter surgeon experienced difficulty with 4 out of 5 cams locks partially locking and the bottom cam lock detached from the plate.On (b)(6) 2019 during follow up radiographs identified both of the inferior screws had backed out with no reported patient symptoms.On (b)(6) 2019 a revision procedure took place where the plate was removed and replaced with another vendor¿s device with no reported issues or patient injury.

• Brand Name: ARCHON ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 8597914
• Report Number: 2031966-2019-00192
• Device Sequence Number: 13976172
• Product Code: KWQ
• UDI-Device Identifier: 00887517202871
• UDI-Public: 887517202871
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K131025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/17/2019

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: 8787474
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1