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

Model Number	1476000500
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/23/2021
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 field representative regarding patient with pre-op diagnosis deformity involved in the correction procedure.It was reported that post-operatively, rod broke, and no fragment left in the patient body.Product was utilized correctly according to the directions given in the ifu/labeling.Patient is alive and no injury.On (b)(6) 2021, received additional information that levels treated/implanted- multi level.Rod popped out & visible from outside the skin.On (b)(6) 2021, received additional information that pain was reported in the patient due to rod popped out.

• Brand Name: CD HORIZON® SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 12793275
• Report Number: 1030489-2021-01367
• Device Sequence Number: 12032877
• Product Code: KWP
• UDI-Device Identifier: 00613994579522
• UDI-Public: 00613994579522
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K091974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/11/2021

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: 1476000500
• Device Catalogue Number: 1476000500
• Device Lot Number: 0538799W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2021
• Initial Report FDA Received Date: 11/11/2021
• Date Device Manufactured: 01/26/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 35 KG