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

Catalog Number	8110855
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
Event or Problem Description
It was reported that patient with degenerative spinal stenosis underwent crosslink placement after t11 pelvis fusion.Intra-op, the set screws broke into two fragments.No fragments remained inside the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual and optical examination identified witness mark on the external hex, consistent with final tightening.Optical, and microscopic examination of the internal hex of the set screw did not identify witness marks consistent with secondary torque.Tl hex driver used during tightening not returned for analysis.Unable to determine root cause of tip shear of the break off set screw¿s from the available information.
Additional Manufacturer Narrative
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: 6215016
• Report Number: 1030489-2016-03608
• Device Sequence Number: 10776324
• Product Code: KWP
• UDI-Device Identifier: 00721902729331
• UDI-Public: 00721902729331
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K030840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2017

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: 8110855
• Device Lot Number: 0486759W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Initial Date Received by Manufacturer: 12/06/2016
• Supplement Date Received by Manufacturer: Not provided; 03/15/2017
• Initial Report FDA Received Date: 12/30/2016
• Supplement Report FDA Received Date: 03/15/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR