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

Catalog Number	7540220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	06/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.X-ray review: in the post-op x-rays for t2- pelvis fixation no obvious hardware malfunction is identified.The patient by report is quadriplegia and there is very little soft tissue.The left side rod appears to be long, otherwise hardware placement appears appropriate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient presented with neuromuscular scoliosis and underwent construct fixation at t2-pelvis.Reportedly post-op, the set screw failed and patient had pseudoarthrosis.On (b)(6) 2018 the patient underwent revision surgery in which the construct was explanted.
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: 7703482
• Report Number: 1030489-2018-01027
• Device Sequence Number: 751464
• Product Code: KWP
• UDI-Device Identifier: 00885074468174
• UDI-Public: 00885074468174
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2018

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: 7540220
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 10/02/2018
• 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: 15 YR
• Patient Weight: 36