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

Catalog Number	8110855
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
Event or Problem Description
It was reported that patient with l3/4 and l5/s1 spondy underwent open navigated l3-s1 with transforaminal lumbar interbody fusion.Intra-op, crosslink was picked according to size for the patient.The scrub tech loaded the crosslink onto the crosslink swizzle sticks and backed out the gold set screws so the crosslink could be placed onto the rods.The surgeon placed the crosslink over the l4/5 space and tightened the set screws into place.The doctor took the t handle and sounded as the surgeon was trying to torque it off.He then tried again and the set screw torqued off in normal fashion.After surgeon had torqued the other side and the center nut, the surgeon noticed that the bottom tip of the set screw had broken and was lying in the wound.Surgeon removed the broken piece and used the removal driver to remove the torqued set screw and then placed a new set screw in the crosslink and torqued it into place with no issues.No patient complications were reported as a result of this event.
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: 6448770
• Report Number: 1030489-2017-00714
• Device Sequence Number: 587973
• Product Code: KWP
• UDI-Device Identifier: 00721902729331
• UDI-Public: 00721902729331
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K030840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2017

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: 8110855
• Device Lot Number: 0476212W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: 03/07/2017
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1