MAUDE Adverse Event Report: SEASPINE INC. ATOLL; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	16-17-0000
Medical Device Problem Codes	Disassembly (1168); Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs confirming the event were received.Dhr review cannot be completed as the product has not been returned because the device remains implanted.Patient activity at the time or prior to the event is unknown.Patient's bone quality is unknown.The degree of spinal instability is unknown.It is unknown if the patient complied with post-operative care instructions or sustained a fall/impact of some sort.Review of labeling notes: warning cautions and precautions, "loosening, bending, dislocation, and/or breakage of the components, possibly requiring further surgery." the root cause of this reported event has not been determined.
Event or Problem Description
Patient's pathology necessitating initial surgery on (b)(6) 2016, was degenerative disc disease and central canal stenosis with facet hypertrophy.Patient had prior two level acdf.The posterior cervical c3- t2 construct disassociated bilaterally from the c3 and c4 laminar screws and c6 on the left side.Patient status is unknown.Surgeon is planning a revision surgery, but patient is out of state and may not come back for corrective surgery.

• Brand Name: ATOLL
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): SEASPINE INC.; carlsbad CA 92008
• MDR Report Key: 5848427
• Report Number: 2032593-2016-00011
• Device Sequence Number: 11163878
• Product Code: KWP
• UDI-Device Identifier: 10889981052867
• UDI-Public: 10889981052867
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K070638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2016

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: Physician
• Device Catalogue Number: 16-17-0000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2016
• Initial Report FDA Received Date: 08/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR