MAUDE Adverse Event Report: SEASPINE INC. CORAL II DEGENERATIVE SYSTEM; SPINAL PEDICLE FIXATION FOR DEGENERATIVE DISC DISEASE

Catalog Number	10-18-0045
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported event photo confirming a broken screw was received.No pictures were received which included part number and/or lot number.Product and product manufacturer confirmed through archived case sheet from index surgery ((b)(6) 2015).No product will be returned as it is being retained by the hospital.No radiographs, mris or medical records had be received.No further evaluation of the product can be completed at this time.Patient has pseudarthrosis, she is a former smoker and has a risk factor from obesity.It is unknown if the patient complied with post-operative care instructions or sustained a fall/impact of some sort.Review of labeling notes warnings and precautions: there are many biological and mechanical factors that affect the longevity of these devices including anatomical stability, patient activity level, and patient's compliance with post-surgical instructions.These internal fixation devices are load sharing devices that hold bony structures in alignment until healing occurs.If healing is delayed, or does not occur, the implant may eventually disassemble, loosen, bend, or break.The long duration (1 year and 5 months) and non-union suggests that the fracture may have been the result of a cyclical fatigue failure.The previous treatment to fuse t2-l5 and the continued pseudarthrosis condition may have contributed to the weight baring state on the inferior portion of the construct causing addition load.Though there are many elements to the event, root cause of this reported event has not been determined, no conclusion can be drawn.Retained by hospital.
Event or Problem Description
((b)(4) 3012120772 2017 00003 & (b)(4) 3012120772 2017 00004 relate to rod and screw for same patient).Prior to 2014, the initial posterior fixation surgery was performed at levels l2 - l4.In 2014, revision surgery occurred to extend construct from level t5 to s1.On (b)(6) 2015 the index surgery for level s2 (screw and rod related to this event), involved re-instrumenting/extending construct from t2 through s2 due to pseudarthrosis at l4 - s1.On (b)(6) 2017 revision surgery occurred for failed iliac screw at s2 and rod fracture at l5-s1.Construct failure was symptomatic due to increased pain and deformity.Additionally the patient had continued pseudoarthrosis.The revision surgery replaced the failed 8.5 x 70mm right illiac screw (s2), in which the shank head had fractured from the bone screw shank.Also, the left 45mm rod fracture was replaced another 45mm rod and bridged with a "u" shaped rod-to-rod connector and also involved autograft and biologics.

• Brand Name: CORAL II DEGENERATIVE SYSTEM
• Common Device Name: SPINAL PEDICLE FIXATION FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 6435756
• Report Number: 3012120772-2017-00004
• Device Sequence Number: 797983
• Product Code: KWQ
• UDI-Device Identifier: 10889981028862
• UDI-Public: 10889981028862
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K041592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2017

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?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 10-18-0045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 03/27/2017
• 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
• Patient Age: 61 YR