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

Model Number	855-011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare professional via manufacturer representative regarding a patient implanted with a rod due to non-specific spondylitis th9-l1, spondylitis stage, peak phase, progression, instability of the dorsal submerged fixing structure.The procedure involved was radiography of the lower section of the gop and pop.Patient's medical history includes transpedicular fixation of the spine, open combined laminar-pedicular metalosteosynthesis th4-6, th9 ,th11, l1-4.It was reported that the rod broke.The implant date is (b)(6) 2019.Broken fragments remained in patient.Backache, fracture of the metal structure at the l1 level with migration of the metal structure.Spinal instability at the level of th12, l1-3.Failed posterior fusion th10, l5 were reported as a result of the event.The rod remains implanted and revision surgery was planned.No further complications were reported.

• 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: 10859431
• Report Number: 1030489-2020-01657
• Device Sequence Number: 11713062
• 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: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2020

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 Model Number: 855-011
• 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: 10/28/2020
• Initial Report FDA Received Date: 11/18/2020
• 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: Required Intervention
• Patient Age: 41 YR
• Patient Weight: 63