MAUDE Adverse Event Report: SEASPINE CABO ANTERIOR CERVICAL PLATE; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	81-1216
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs confirming the event were received.Dhr review and product investigation cannot be completed as the product has not been returned because the device remains implanted.It is unknown if the patient complied with post-op care instructions.The patient's activity level will dictate the longevity of the implant.Review of labeling notes: "possible adverse events bending, disassembly or fracture of implant and components.Loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.Postoperative fracture due to trauma, defects or poor bone stock." postoperative warnings: the patient should be advised that implants may bend, break or loosen despite restriction in activity.The root cause is unknown, as multiple attempts have been made to acquire additional information to no avail.No conclusions can be drawn.
Event or Problem Description
Initial acdf surgery at c7-t1 was performed on (b)(6) 2017.During a routine follow up, it was noted that the 16 mm superior bone screw had fractured and backed out from the anterior cervical plate.Patient is fully fused.Surgeon is monitoring the patient, and no revision surgery is currently planned.Patient bone quality is unknown.It is unknown the patient's activity level post-op.It is unknown if the patient complied w/postoperative care instructions.

• Brand Name: CABO ANTERIOR CERVICAL PLATE
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): SEASPINE; 5770 armada drive; carlsbad,
• MDR Report Key: 7853378
• Report Number: 3012120772-2018-00019
• Device Sequence Number: 19121580
• Product Code: KWQ
• UDI-Device Identifier: 10889981160722
• UDI-Public: 10889981160722
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2018

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: 81-1216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR