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

Catalog Number	5540230
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis- visual, microscopic and functional evaluation of the returned set screw revealed that head had broken off the set screw.The screw showed varying degrees of damage done the outer diameter (o.D) of threads.There is vertical shearing of the thread located on only one section or side.This type of failure is consistent with the set screw being pushed to one side of the bone screw head while reducing the rod.This uneven loading could allow the o.D.Of the set screw to be overcome by force.The bone screws and the rods were returned for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent an unknown spinal surgery due to adolescent idiopathic scoliosis at t4-l3.Intra-op, set screw stripped.Initially, surgeon reduced the rod, started screws, and did provisional tightening & compression/distraction of implants.Surgeon then removed smart links and set screw was threaded correctly with no cross threading (visual inspection) occurred till then.Surgeon went to break off set screw with instrument and the set screw on the left side all would have an audible click before they broke off.Upon inspection, the medial side of the set screw skipped up a thread and was no longer sitting flush.These were not cross threaded before final break off.

• 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: 7517649
• Report Number: 1030489-2018-00704
• Device Sequence Number: 1176239
• Product Code: KWP
• UDI-Device Identifier: 00643169058750
• UDI-Public: 00643169058750
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5540230
• Device Lot Number: 0620624W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 62