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

Catalog Number	X0212513
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent scoliosis correction surgery at t3-l3.Intra-op, when surgeon applied force to the segmental derotators, the screw head got deformed in the coronal plane; which ultimately plowed through the lateral vertebral wall of left side l1 (away from the spinal cord).The screw was then completely explanted.This level was left un-instrumented after the event.The patient had a stiff double major scoliotic curve.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual and optical inspection did not reveal any damage to the head or threads of the bone screw.Functional inspection confirmed the screw has been angulated and will no longer pivot inside the crown of the screw head.Dimensional check confirmed the bone screw was made to print specification.Root cause for the reported event could not be determined.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: 8677999
• Report Number: 1030489-2019-00610
• Device Sequence Number: 2212437
• Product Code: KWP
• UDI-Device Identifier: 00643169606951
• UDI-Public: 00643169606951
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K130646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: X0212513
• Device Lot Number: 0677130W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Weight: 44