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

Catalog Number	855-011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other: pain.Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported 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 reconstructive and corrective surgery for polysegmental lesion of the spine with application of implants, stabilizing system for the patient due to tuberculous spondilitis.Post-op, legacy rod broke.The model of patient: polysegmental (4 or more vertebrae) and specific tuberculous of the thoracic and lumbar spine.The patient underwent replacement of transpedicular stabilization system and suffered from pain as a result of this event as a result of alleged event.

• 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: 9393666
• Report Number: 1030489-2019-01359
• Device Sequence Number: 2852433
• Product Code: KWP
• UDI-Device Identifier: 00673978061825
• UDI-Public: 00673978061825
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K954645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 855-011
• Device Lot Number: 0319078W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 30 YR
• Patient Weight: 47