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

Catalog Number	8672065
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); No Code Available (3191)
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.
Event or Problem Description
Date of revision surgery: (b)(6) 2016 (month and year valid) it was reported that on an unknown date, post-op, patient suffered with pain due to the surgeon implanting rods that were too long.The rods caused damage to her iliac bone.The patient stated that the cages were crammed in there.Patient underwent a revision surgery but due to the damaged done by the first surgery, patient was not able to have fusion.Patient underwent revision surgery and the rod was explanted.New rods and screws were placed.No hardware failure or breakage was observed.
Additional Manufacturer Narrative
Image review: post-op x-rays provided for l4-s1 fusion interbody devices present at l4-5, l5-s1.Appears to be a paucity of bone graft.Ap images only.Unclear if these are initial post-op, or post revision x-rays, but the rods in this x-ray appear to be a suitable length.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6165671
• Report Number: 1030489-2016-03390
• Device Sequence Number: 16245015
• Product Code: KWP
• UDI-Device Identifier: 00721902180323
• UDI-Public: 00721902180323
• Combination Product (Y/N): N
• PMA/510(K) Number: K143141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/20/2019

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: Health Professional
• Device Catalogue Number: 8672065
• Device Lot Number: 022950W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2016
• Supplement Date Received by Manufacturer: Not provided; 12/13/2016; 02/19/2019
• Initial Report FDA Received Date: 12/12/2016
• Supplement Report FDA Received Date: 12/14/2016; 09/27/2017; 03/20/2019
• 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: Other; Required Intervention