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	11/06/2017
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.
Event or Problem Description
It was reported that the patient underwent decompression and fusion at t2-t9.Intra-op, one of the lateral set screws split in two.No fragments of the product remained inside the patient.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.Product analysis result: visual microscopic visually confirmed the set screw is fractured at the proximal tip of the implant.The fracture surface appears to emanate from and follows the root of the internal thread tooth upward, and appears to be approximately parallel with the root of the tooth angulation, and has shear lines on the fracture surface.The internal hex has witness marks, and the break-off portion of the set screw is not broken off, suggesting the set screw was tightened utilizing the internal hex, which would prevent the break-off portion from being broke-off.The above observations are consistent with torsional overload.If information is provided in the future, a supplemental report will be issued.
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: 7074006
• Report Number: 1030489-2017-02417
• Device Sequence Number: 19118994
• Product Code: KWP
• UDI-Device Identifier: 00721902729331
• UDI-Public: 00721902729331
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 8110855
• Device Lot Number: 0035855W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 04/24/2018; 06/11/2018; 08/08/2018
• Initial Report FDA Received Date: 12/01/2017
• Supplement Report FDA Received Date: 05/24/2018; 07/10/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1