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

Model Number	8115545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent l5 spinal reduction and interbody fusion internal fixation due to spondylolisthesis of the l5 bilateral isthmus and l5-s1 latent fissure.Intra-op, when the doctor completed the implantation and locked the screw, the screw broke.The device came in contact with the patient.No fragments of the device remained inside the patient.No patient complications were reported due to this event.
Additional Manufacturer Narrative
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.The outer hex does not appear to be damaged however, the inner hex does show signs of deformation.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: 7572746
• Report Number: 1030489-2018-00809
• Device Sequence Number: 18873752
• Product Code: KWP
• UDI-Device Identifier: 00721902729713
• UDI-Public: 00721902729713
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2018

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 Model Number: 8115545
• Device Catalogue Number: 8115545
• Device Lot Number: 0627432W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 09/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR