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

Catalog Number	1555501040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not 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
The patient was pre-operatively diagnosis with lythesis and underwent open fusion at l3/4.Post-op, the implanted rod broke.Patient underwent revision surgery as a result of this event.
Additional Manufacturer Narrative
Product analysis results: visual microscopic dimensional the returned rod appeared to be broken.No pre-existing surface defects were identified that could contribute to the breaks.A microscopic review of the fracture surface reveals an area of crack propagation with a sheer lip on the other side of the fracture face.There did not appear to be any evidence of cyclic fatigue across the fracture face.Both the area of crack propagation and the sheer lip are in plane with the location of the set screw witness mark.The previous observations are consistent with bend stress overload.Radiological image review results: images provided for l3-4 tlif.Post-op x-rays show rod fracture at l3-4 with a paucity of bone graft and the interbody space under what the amount of time post-op or before hardware failure.Patient is noted to be a smoker.Hardware placement otherwise appears appropriate.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: 8626842
• Report Number: 1030489-2019-00563
• Device Sequence Number: 14017468
• Product Code: KWP
• UDI-Device Identifier: 00643169081222
• UDI-Public: 00643169081222
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1555501040
• Device Lot Number: 0553631W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 07/23/2019
• 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: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 75