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

Catalog Number	8115528
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported event.Image review: submitted image appears to display set screw broken off at the root of the thread.
Event or Problem Description
It was reported that the patient underwent lumbar surgery in which surgeon had to drill out failed device with metal cutting burr and replace with a new device.Set screw broke in the wrong location causing the device to be stuck on the rod without being able to tighten.All fragments were removed.Complications involved explanting the broken device utilizing a metal cutting burr.Patient issue was resolved.Different crosslink was used in place of broken device.No patient complications were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: product analysis: visually confirmed the set screw is fractured approximately 1 thread up from the distal tip of the set screw.The broken off portion of the set screw was not returned for analysis.Microscopic examination of the fracture surface appears to emanate from the root of the thread, following the thread helix, with downward deformation of the sheared portion of the thread.Functional evaluation of the threaded portion of the set screw above the fracture appears to be undamaged and able to engage into the crosslink body without issue.The above observations are consistent with torsional shearing of the thread during tightening.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: 6529116
• Report Number: 1030489-2017-01065
• Device Sequence Number: 1268251
• Product Code: KWP
• UDI-Device Identifier: 00721902729522
• UDI-Public: 00721902729522
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 05/31/2017

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: 8115528
• Device Lot Number: 0459082W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: Not provided; 05/31/2017
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 06/28/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR