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

Catalog Number	55410006540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Product image review: submitted images appear to display implant broken off approximately ~4 threads down from the bone screw head.
Event or Problem Description
Pre-operative diagnosis for this procedure: revision surgery (l2-s1) because of the broken screws in s1 levels implanted: s1 it was reported that the patient underwent surgery from l2-s1 with fixed angle screws.Post-op, s1 screw was broken and revision surgery was performed to remove the screw.The distal half of the screw remained in the patient.It was reported that patient had construction failure.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that on (b)(6) 2017 the patient was with the doctor and the doctor suspected that the screw was broken.
Additional Manufacturer Narrative
Product analysis-visual and optical examination of fas bone screw confirms breakage approximately ~4 threads from the base of the bone screw head.Visual and optical examination of the adjacent surfaces to the area of crack propagation does not identify a surface defect which could contribute to the foregoing fracture.Optical and microscopic examination reveals significant secondary (post-fracture) damage to the fracture surface.Undamaged areas of fracture surface display progressive convex striations and beach marks through the cross-sectional area of the bone screw, until subsequent mechanical failure.The above observations are consistent with cyclic fatigue.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: 6833453
• Report Number: 1030489-2017-01981
• Device Sequence Number: 65705
• Product Code: KWP
• UDI-Device Identifier: 00643169074002
• UDI-Public: 00643169074002
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2017

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: 55410006540
• Device Lot Number: 0278213W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Initial Date Received by Manufacturer: 08/04/2017
• Supplement Date Received by Manufacturer: 09/06/2017; 11/13/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 10/04/2017; 12/07/2017
• 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: 60 YR