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

Model Number	20-0472
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient current status is unknown.No product have been returned as no revision surgery has been reported.No product information was given, and no further evaluation of the product can be completed at this time.Radiograph received confirms the plate and bone screw disassociation from the vertebral bodies.There is no evidence that the implant malfunctioned and the construct is locked and intact.It is unknown what caused the cervical plating system to disassociate from the vertebral bodies.Bone quality is unknown, but the spinal segments are less than optimal.It is unknown if the patient followed post-operative instructions or sustained a fall that may have contributed to the implant's disassociation.No conclusion can be drawn.Labeling review: possible adverse events: delayed union or nonunion (pseudarthrosis), 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.Labeling warnings and precautions: based on the fatigue testing results, the surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions,.
Event or Problem Description
Radiograph received depicting a 4 level cervical plate with bone screws detached from the c3-c7 vertebral bodies.The bone screws are still locked and secured in place in the plate.The four un-identified allograft have slightly shifted anteriorly.It appears, the three caudal vertebral bodies (c5, c6 and c7) have slightly collapsed and column is not aligned.Multiple attempts to gain information about the event have been made, with no success.Based on the surgeon name and the hardware displayed in the radiograph, suggests the original surgery was likely (b)(6) 2016.Current patient status/condition is unknown.It is not known what corrective action was taken or if a revision has occurred.Based on the disassociation of the plate, revision surgery is likely.

• Brand Name: ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION APPLIANCE
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 6571390
• Report Number: 3012120772-2017-00005
• Device Sequence Number: 13486217
• Product Code: KWQ
• UDI-Device Identifier: 10889981050993
• UDI-Public: 10889981050993
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K032368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/18/2017

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: Physician
• Device Model Number: 20-0472
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 05/16/2017
• 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