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

Catalog Number	8115539
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2017
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 reported event.Image review: submitted images appear to display instrument set screw tips broken off.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-operative diagnosis for procedure: lumbar spinal stenosis it was reported that during surgery, the nut of the crosslink ruptured.The product broke and no fragment remained in the patient.The product was replaced and the surgery completed without any complications.

• 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: 6823334
• Report Number: 1030489-2017-01964
• Device Sequence Number: 1089958
• Product Code: KWP
• UDI-Device Identifier: 00721902729690
• UDI-Public: 00721902729690
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2017

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: 8115539
• Device Lot Number: 0534145W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2017
• Initial Report FDA Received Date: 08/28/2017
• 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