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

Catalog Number	7049855
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The product is not returned to manufacturer for evaluation but x-rays were reviewed.X-ray review: "post op x-rays from t11-ilium show vertebrae placed with substantial residual deformity.The rod is noted to be out of the superior screw heads on the convex side of the scoliosis.The rod does not appear to be properly contoured for the uncorrected deformity and this is the likely failure mode.".
Event or Problem Description
It was reported that patient with preoperative diagnosis of neuromuscular scoliosis, paraparesis underwent fusion procedure at levels th11-iliac.On unknown date, post-op, the set screw got disconnected from the illiac connector.On (b)(6) 2017 a revision surgery took place where it was explanted.The rod had been slipped out and translated from screws.No malfunction reported with rod.The surgeon replaced the cocr rods with ti alloy rods for more flexibility on patient fusion.Changing body position(increased kyphosis) was reported as the result of the event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported during follow up that this relevant set screw didn't loosen.

• 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: 6783893
• Report Number: 1030489-2017-01905
• Device Sequence Number: 1490796
• Product Code: KWP
• UDI-Device Identifier: 00613994171108
• UDI-Public: 00613994171108
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K040962
• 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): 09/05/2017

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: 7049855
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2017
• Supplement Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 09/19/2017
• 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: 21 YR