MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	869-011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Image review: post-op, and pre revision x-rays show large segment thoracolumbar fusion with hook and pedicle screw construct.Ct images demonstrate fusion across the lumbar facets with a rod fracture at l1 at the thoracolumbar transition zone.There is no instrumentation at this level.The overall degree of deformity correction appears adequate.Suspect construct failure as a result of excessive motion at unfused transitional segment.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-operative diagnosis:revision after hyperkyphosis level:l1 procedure:implanting screws and rods it was reported on an unknown date rod broke post-operatively.The patient heard a pop sound while bending.Patient underwent a revision surgery for removal.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6662661
• Report Number: 1030489-2017-01611
• Device Sequence Number: 45913
• Product Code: KWP
• UDI-Device Identifier: 00721902750991
• UDI-Public: 00721902750991
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K031655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2017

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: Health Professional
• Device Catalogue Number: 869-011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2017
• Supplement Date Received by Manufacturer: 05/29/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 09/07/2017
• 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: 58 YR