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

Catalog Number	55840016545
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
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.
Event or Problem Description
Pre-op diagnosis: spondylolisthesis l4/5 grade i meyerding procedure: spondylodese l4/5 360 degrees levels implanted: l4/5 it was reported that post-op, the implanted screw broke.A revision surgery was performed to remove the broken screw.No patient com plications were reported as a result of the event.
Additional Manufacturer Narrative
Product analysis result: visual microscopic the bone screw has broken approximately 41mm from the tip.There are witness marks on the saddle of the bone screw that would indicate the rod was sitting at an extreme angle inside the head.The bone screw appears to have been locked in at max angulation.When the fracture surface of the bone screw was examined microscopically fatigue lines could be seen running through the face of the fracture.Do to the damage of the fracture surface only a portion of the surface is visible.It appears that repeated force place on the bone screw caused a cyclic fatigue failure, the angulation of the screw did not help.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
X-ray review result: post-op ct scan of broken screw revealed that there is a paucity of bone graft present in the interbody space.Hardware placement appears appropriate on intra-op images.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: 6896761
• Report Number: 1030489-2017-02121
• Device Sequence Number: 16343806
• Product Code: KWP
• UDI-Device Identifier: 00643169077423
• UDI-Public: 00643169077423
• 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: 2016
• 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): 12/29/2017

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: 55840016545
• Device Lot Number: H5293750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Initial Date Received by Manufacturer: 09/03/2017
• Supplement Date Received by Manufacturer: 10/24/2017; 12/08/2017
• Initial Report FDA Received Date: 09/27/2017
• Supplement Report FDA Received Date: 11/09/2017; 12/29/2017
• 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: 66 YR
• Patient Weight: 112