MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	75445545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2018
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 was pre-operatively diagnosed with degenerative disc disease and underwent posterior stabilization surgery at l4-l5-s1 levels.Post-operatively, the screw was found broken on the right side of s1.The patient has achieved solid fusion.No patient complications were reported.
Additional Manufacturer Narrative
Additional information: product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.X-ray review: post op lateral x-rays of l4-s1 fusion shows a single broken screw at s1.It is also reported the patient has achieved solid fusion at the l4 month start point.Head cone placement appears appropriate.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: visual review confirms screw breakage ~3 threads down from the base of the bone screw head.Visual and microscopic examination of the area of fracture initiation did not identify a pre-existing surface defect near the area of crack origination that could contribute to crack propagation.Microscopic examination of the fracture surface identified gently convex progressive striations through the cross-sectional area of the bone screw, consistent with cyclic fatigue.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): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 7636641
• Report Number: 1030489-2018-00902
• Device Sequence Number: 16747320
• Product Code: KWP
• UDI-Device Identifier: 00885074134024
• UDI-Public: 00885074134024
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K042025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2018

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: 75445545
• Device Lot Number: H5378485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 06/27/2018; 08/21/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 07/24/2018; 09/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR